Unsedated endoscopy

Gastrointest Endoscopy Clin N Am

14 (2004) 369–383

Unsedated endoscopy

Elizabeth J. Carey, MD, Darius Sorbi, MD*

Division of Gastroenterology and Hepatology, Mayo Clinic Scottsdale, 13400 E Shea Blvd,

Scottsdale, AZ 85259, USA

The evolution of gastrointestinal (GI) endoscopy in the United States has

led to the near-universal practice of performing all endoscopic procedures other

than flexible sigmoidoscopy under conscious sedation. Although most American

patients expect to receive sedation in the endoscopy suite, some GI procedures

in other countries are routinely performed without amnestic or narcotic agents

[1,2].

Performing endoscopy without sedation has intuitive benefits. Because the

majority of endoscopic complications are cardiopulmonary problems secondary

to sedation, preventing these complications would make the examination safer for

patients [3]. Unsedated endoscopy may be more convenient for patients because

they are able to return to normal activities immediately after the examination and

because an additional person is not required to drive them home. Furthermore,

much of the expense of endoscopy is related to the use of cardiopulmonary

monitoring during and after sedation and to the recovery time after the procedure.

Procedures done without sedation require less time, less monitoring, and fewer

ancillary personnel and impart fewer risks for the patient. The affordability of

screening and diagnostic testing will play an increasingly larger role as the health

care system continues to manage its financial crisis.

The benefits of unsedated endoscopy must be weighed against the possible

disadvantages. Foremost is the concern that a high percentage of examinations

will be prematurely aborted due to patient discomfort. Second is the concern of

compliance—patients might be unwilling to return for a repeat endoscopy if they

found the first examination distasteful. Finally, there are technical concerns.

Unsedated endoscopy is generally performed with endoscopes having a smaller

outer diameter (OD) and a smaller instrument channel. Due to their small size,

many of these instruments have limited capabilities for taking biopsies and per-

forming therapeutic procedures. The benefits of unsedated endoscopy will be

quickly overwhelmed if a significant proportion of patients require the exami-

nation to be repeated in the traditional fashion.

1052-5157/04/$ – see front matter D 2004 Elsevier Inc. All rights reserved.

doi:10.1016/j.giec.2004.01.003

* Corresponding author.

E-mail address: [email protected] (D. Sorbi).

E.J. Carey, D. Sorbi / Gastrointest Endoscopy Clin N Am 14 (2004) 369–383370

This article reviews the technical aspects of unsedated endoscopy; evaluates

its feasibility, tolerability, and accuracy; and reviews the current practice of

unsedated endoscopy in the United States. Unsedated upper endoscopy has re-

ceived the most attention in the literature and is more thoroughly reviewed here

than unsedated colonoscopy, on which the literature is scant.

Unsedated upper endoscopy

Esophagogastroduodenoscopy (EGD) using small-caliber endoscopes may

be the most promising application of unsedated endoscopy. Most EGDs are

done for diagnostic purposes, and unsedated examinations may be completed in

under 10 minutes [4–6]. Because of the short duration and lack of therapeu-

tic intervention in many EGDs, this procedure is a natural candidate for unse-

dated endoscopy.

Technical aspects

Ultrathin video and fiberoptic endoscopes are available for transnasal or

transoral intubations. Transnasal endoscopy is performed using endoscopes with

an OD of 6 mm or less. Video esophagogastroduodenoscopes and esophago-

scopes are available. Table 1 lists the specifications of small-caliber endoscopes.

The OD of the video esophagogastroduodenoscopes ranges from 5.1 to 6 mm,

and the esophagoscopes have an OD of 3.1 to 4 mm (Fig. 1A). Some small-

Table 1

Fiberoptic and video small-caliber endoscopes available for unsedated upper endoscopy. The endo-

scopes with a working length of 600 mm are used for esophagoscopy only. Some esophagoscopes are

battery operated

Company, model Imaging

Outer

diametera (mm)

Working

length (mm)

Instrument

channel (mm)

Angulation

(up/down-right/left)

Pentax

EG-1540 Video 5.1 1050 2.0 210/120-0/0

EG-1840 Video 6.0 1050 2.0 210/120-120/120

Olympus

GIF-XP160 Video 5.9 1030 2.0 180/90-100/100

GIF-N230 Video 6.0 930 2.0 180/180-160/160

XGIF-N160Y1 Video 5.3 1330 2.0 180/180-0/0

GIF-N30 Fiberoptic 5.3 930 2.0 180/180-160/160

GIF-XP20 Fiberoptic 7.9 1030 2.0 210/90-100/100

XEF-DPb Fiberoptic 3.1 600 – 90/90-0/0

LF-GPb Fiberoptic 4 600 – 90/90-0/0

XEF 140I Video 4 600 – 90/90-0/0

Fujinon

EG-470 N/

EG-270 N

Video 6.0 1100 2.0 210/90-100/100

a Values correspond to the outside diameter of the insertion tube.b Denotes battery-operated esophagoscope.

Fig. 1. (A) Small-caliber upper endoscope. The distal ends of a small caliber, a pediatric, and a con-

ventional esophagogastroduodenoscope are shown. (B) Small-caliber esophagogastroduodenoscope

with only one ratchet for up/down control.

E.J. Carey, D. Sorbi / Gastrointest Endoscopy Clin N Am 14 (2004) 369–383 371

caliber endoscopes have only one ratchet for up and down movement, whereas

others allow for right-left and up-down angulation (Fig. 1B).

Unsedated upper endoscopy can be performed in the left lateral decubitus

position or in an upright sitting position. An unsedated patient sitting upright

would seem to have the lowest risk of aspiration, but this has not been formally

studied. Because the patient is awake and alert, the endoscopy staff must take

care to behave in a calm and professional manner. The endoscopist should be

aware that his or her demeanor sets the tone for the examination and should

approach the patient in a reassuring and comfortable manner. Movements should

be slow, gentle, and meaningful and should impart neither haste nor inexperience.

Air insufflation should be kept to a minimum. The endoscopist should speak to

the patient throughout the procedure, explaining each step and demonstrating

findings on the video monitor.

Transnasal and transoral approaches have been described; neither is clearly

superior in terms of patient safety or tolerability. The approach chosen is de-

termined by the endoscopist’s experience, patient preference, and endoscope

diameter. Transnasal intubation should be limited to endoscopes with an OD of


6 mm or less. Topical anesthesia should be used for transnasal and transoral

intubations. Transnasal intubation should be preceded by the application of

lidocaine jelly to the nares, and pharyngeal anesthesia is recommended for both

approaches. Local vasoconstrictors may be helpful to minimize epistaxis when

transnasal endoscopy is performed with larger (6-mm) endoscopes.

Small-caliber endoscopy may limit the ability to perform biopsies. The 4-mm

or smaller endoscopes are intended for diagnostic purposes only and do not have

a biopsy channel. The 5.1- to 6-mm instruments have a 2-mm accessory channel

through which pediatric biopsy forceps may be passed.

Unlike sedated endoscopy, the patient is free to resume his or her activities

almost immediately after completion of the procedure. Post-procedure stay in the

recovery room, if necessary, is brief. Patients can generally be discharged once

the gag reflex has returned.

Feasibility

The feasibility of a procedure is a general assessment by the endoscopist that

broadly describes its success. A number of factors, objective and subjective, are

incorporated into this assessment: instrument maneuverability, image quality, pa-

tient tolerance, and endoscopist comfort. A number of studies report on the

feasibility of small-caliber or unsedated EGD. Many of these studies, however,

were not performed in a prospective, randomized, or controlled fashion, which

limits the strength of the data.

Transoral unsedated small-caliber EGD (sc-EGD) is associated with a success

rate of 85% to 100%. In a study of 20 American volunteers, unsedated sc-EGD

(OD 6 mm) was feasible in 100% of the cases. Symptoms of choking and dis-

comfort were higher in unsedated versus sedated volunteers, but this did not

interfere with the technical success of the examination [7]. In a subsequent phase

of the same study, unsedated sc-EGD was technically feasible in 38 of 40 patients

(95%). In one case, the patient was unable to tolerate the examination, and in the

second case, the postbulbar duodenum was not intubated. A British study

randomized 322 patients to unsedated sc-EGD (OD 6 mm) versus unsedated

EGD with a standard instrument (OD 9.8 mm). Successful completion of the

procedure occurred more often in the sc-EGD group than the larger diameter

group: 160 of 163 (98%) versus 145 out of 159 (91%), respectively [8]. In 72 US

Air Force members randomized to sc-EGD (6.0 mm) versus c-EGD, there was

no difference in duodenal intubation rates (97% versus 100%), but sc-EGD

was associated with impaired gastric retroflexion (85% versus 100%) [9]. Use

of a 3.1-mm, battery-powered esophagoscope was successful in 100% of 28 cir-

rhotic patients undergoing routine screening for esophageal varices [10]. In one

case, the instrument had to be removed to clear the lens of thick mucus. The

patient was reintubated, and the remainder of the examination was successful. This

study was limited to examination of the esophagus and the gastroesophageal

junction, so factors such as gastric retroflexion and duodenal intubation were

not assessed.


The transnasal approach has also been studied in unsedated sc-EGD. The pro-

cedure was successful in 173 patients (96%) of 181 Spanish patients randomized

to transnasal or transoral unsedated sc-EGD (OD 5.3 mm) [11]. Initial intubation

could not be achieved in four patients in the transnasal group and in two in the

transoral group. Furthermore, duodenal intubation was not accomplished in one

patient from the transnasal group. Two patients in the transoral group did not tol-

erate the procedure, and the examination was incomplete in those patients. A

complete examination was achieved in 95% of the transnasal group. Success was

achieved in 96% of the transoral group, but 15% of this group also received in-

travenous sedation. A similar comparison was made in 170 Australian patients

[12]. A complete examination was feasible in 74 of 84 (88%) patients in the

transnasal group and 85 of 86 (99%) of the transoral group (P = 0.004). A com-

parison of transoral and transnasal sc-EGD using a prospective randomized cross-

over study design yielded a success rate of 97% transorally and 86% transnasally

[13]. Saeian et al [14] reported a 100% success rate of transnasal sc-EGD (5.3 mm)

in an uncontrolled group of 15 patients. In the largest series, unsedated transnasal

sc-EGD (5.3-mm and 5.9-mm endoscopes) was attempted in 1100 patients in three

French medical centers [15]. The procedure was feasible in 94% of the patients,

with unsuccessful transnasal insertion being the most common reason for failure.

In summary, unsedated sc-EGD is a feasible test in most circumstances. The

transnasal approach is associated with a lower success rate, although many

patients who fail this approach are able to have a successful transoral examina-

tion. Most of the studies are small and may have failed to detect a difference due

to a type II error (failure to detect a difference when one exists). Furthermore,

none has sufficient power to determine whether unsedated sc-EGD is feasible

for all indications or whether the transnasal approach is associated with a success

rate comparable to the transoral approach.

Adequacy

Another important contributor to the acceptance of sc-EGD is the endoscopist’s

evaluation of the adequacy of the test. There are a number of factors that com-

prise adequacy: image quality, suctioning ability, tissue sampling, and the ability

to perform therapeutic maneuvers. Table 1 lists the specifications of several small-

caliber upper endoscopes. The variety of small-caliber endoscopes makes com-

parison between instruments difficult. Most small-caliber instruments incorporate

video CCD technology, although some studies have been performed with fiber-

optic instruments. The video small-caliber esophagogastroduodenoscopes provide

images comparable to conventional endoscopy (Fig. 2). Esophagogastroscopes

have a working length of 600 mm, whereas esophagogastroduodenoscopes have a

working length of 1030 to 1330 mm. The 3.1- to 4-mm diameter instruments do

not have an accessory channel, precluding the ability to take biopsies or perform

interventions. The 5- to 6-mm diameter endoscopes have a 2.0-mm accessory

channel. This permits the passage of pediatric biopsy forceps, but standard size

biopsies are not obtainable.

Fig. 2. (Left) Squamo-columnar junction as viewed by a small-caliber esophagogastroduodenoscope.

(Right) Pylorus as viewed by a small-caliber esophagogastroduodenoscope.


A number of studies have addressed the adequacy of sc-EGD. Wildi et al [16]

assessed the diagnostic accuracy of sedated esophagoscopy performed by a nurse

practitioner using a 4.0-mm esophagoscope compared with conventional sedated

EGD performed by an experienced gastroenterologist. Forty patients underwent

tandem procedures in a blinded fashion. The sensitivity and specificity of the nurse

practitioner for all esophageal lesions were 75% and 98%, respectively. Four of

four rings were missed (three of these were considered not clinically significant).

Catanzaro et al [17] reported a sensitivity, accuracy, and specificity of 91%, 98%,

and 99%, respectively, for detecting all esophageal lesions in 51 patients using a

4-mm esophagoscope [17]. A battery-powered fiberoptic esophagoscope was used

for the first 24 patients in the study, and a video esophagoscope was used for

the other 27 patients. They compared their results from an earlier study in which a

3.1-mm, battery-powered endoscope was used. The 4-mm video endoscope was

judged to have optical quality comparable to a standard upper endoscope and was

significantly better than the 3.1-mm, battery-powered instrument. Detection of

pathology with the 3.1-mm instrument was also worse. The sensitivities for de-

tecting Barrett’s esophagus, esophageal tumors, and esophageal varices were 54%,

67%, and 80%, respectively [18]. A sensitivity of 92% and a specificity of 100%

were reported using a 6.0-mm endoscope in 43 patients [6]. Five of 59 lesions

were missed: three small hiatal hernias and two small gastric erosions. Image

quality was good in 84%, 65%, and 78% in the esophagus, stomach, and duo-

denum, respectively. Dean et al [19] found a sensitivity of 89% and a speci-

ficity of 97% in 24 patients undergoing unsedated sc-EGD with a 5.3-mm OD

instrument [19].

The only study to evaluate the effect of sedation on accuracy in sc-EGD found

an accuracy of 96% in patients who underwent sedated sc-EGD and 97% in those

who underwent unsedated sc-EGD [7]. In the largest series to date, biopsies were

taken in 457 of 1100 patients undergoing sc-EGD with a 5.3-mm endoscope. All


biopsy specimens were considered adequate for diagnosis, although this was

neither a primary nor a secondary aim of the study [15]. Despite using pediatric

biopsy forceps, histopathologic detection of Barrett’s esophagus with unsedated

transnasal sc-EGD was determined to be equivalent to conventional EGD in a

study of 32 patients [20].

Various authors report technical problems that may limit the accuracy of

sc-EGD. Looping in the stomach due to the higher flexibility of the small-caliber

instruments may limit evaluation of the duodenum. Image quality may be

compromised by secretions or bubbles that are difficult to clear [7,10,19]. Having

the patient sip a dilute solution of simethicone shortly before the procedure may

enhance clearance of secretions. Air insufflation has been reported to be inade-

quate at times [10].

There are a few upper GI lesions that may not be amenable to diagnosis with

sc-EGD. Rings or strictures are especially hard to detect with a small-caliber

instrument. In fact, 100% of rings were missed in one study [16], and other authors

confirm the difficulty appreciating this finding [7,19]. The degree of air insuffla-

tion during sc-EGD may also affect diagnostic accuracy. Flattening under air

insufflation is an essential component in the grading of esophageal varices. One

study found varices with a battery-powered endoscope that were not confirmed on

standard EGD [10].

Small-caliber upper endoscopy is associated with a slightly lower accuracy

than conventional EGD. Current literature suggests that sc-EGD may be accept-

able for common, readily visible lesions; however, its accuracy in subtle mucosal

lesions has not been assessed. Some problems may be amenable to technical

advances in the future. For example, less flexible or variable stiffness instruments

could minimize looping in the stomach, which would likely increase visualization

of the duodenum. Problems related to air insufflation, aspiration of secretions, or

lens visibility may also be improved with technical modifications.

Tolerability

Even the most successful procedure is unlikely to play an important role in

clinical medicine if it is not accepted by patients. Tolerance of a procedure is a

complex concept that encompasses a broad range of specific symptoms and

expectations. There is wide cultural variation in how patients perceive discomfort

during procedures. It is also important to identify how tolerance is assessed in

studies. Current studies may overestimate patient tolerance because 10% to 40%

of eligible patients refuse to participate in unsedated endoscopy research in the

United States [6,13,17,21]. Thus, the patients most likely to tolerate an unsedated

examination might be over-represented in the literature.

A crude estimate of patient tolerance is the willingness of a patient to undergo

the same examination in the future. Current literature cites a wide range of the

number of patients willing to undergo repeat unsedated endoscopy. In an

uncontrolled study of 1100 patients in France who underwent unsedated transnasal

sc-EGD, 95% of the patients said they would agree to undergo the procedure in the


future [15]. More specific measures of patient tolerance were not assessed. A

recent report by Catenzaro et al [17] describes a high level of tolerance in patients

undergoing unsedated sc-EGD using a 4-mm endoscope. The approach was

transoral in 18 patients and transnasal in 12 patients; the route was chosen by

the patient. The overall discomfort level was low and compared favorably with a

historical group of patients examined with a 3.1-mm instrument. Faulx et al [21]

approached 98 patients scheduled for c-EGD to undergo unsedated sc-EGD using

a 3.1-mm, battery-powered instrument immediately before sedated c-EGD.

Thirty-three percent elected the transnasal approach, and 67% chose a transoral

approach. Fewer than 50% of the patients stated that they would prefer unsedated

endoscopy in the future, although patients who had chosen the transoral approach

were significantly more likely to prefer unsedated sc-EGD in the future compared

with those who had chosen a transnasal route [21]. Although one may argue that

this study was affected by patient unwillingness to undergo tandem endoscopies, it

is one of the few well-designed studies to address the impact of unsedated EGD on

the daily practice of upper endoscopy in the United States. Mulcahy’s cohort of

322 patients randomized to unsedated EGD with a small-caliber instrument versus

a conventional instrument revealed that only 14% of the sc-EGD group felt they

would want sedation for future procedures, in comparison with 31% of the c-EGD

group [8]. Twenty-seven of 28 (96%) cirrhotic patients undergoing unsedated

sc-EGD with a 3.1-mm, battery-powered endoscope to screen for varices reported

that they would prefer unsedated endoscopy in the future [10].

The literature on unsedated EGD using standard-caliber instruments (9.8 mm

or 11.3 mm) yields conflicting results. A discomfort level of ‘‘acceptable’’ during

unsedated endoscopy was achieved in only 61% of 268 Canadian patients [4].

A United Kingdom trial of 62 elderly patients (mean age 79 years) found that an

equal number of patients undergoing sedated or unsedated EGD described the

procedure as ‘‘mildly unpleasant.’’ The majority of unsedated patients, however,

did not wish for sedation in the future [22]. A prospective randomized controlled

trial from the United Kingdom concluded that endoscopists found unsedated ex-

aminations easier but that patients reported significantly greater comfort with

sedation [23]. Froehlich et al [24] randomized 200 European patients to receive

IV midazolam with lidocaine spray, IV placebo with lidocaine spray, IV

midazolam with placebo spray, or IV placebo with placebo spray and found that

patient tolerance was greatest in the groups that received midazolam.

The amount of intra-procedure discomfort experienced by patients is difficult

to assess. Although many authors describe measures of tolerance, the scales used

and the symptoms assessed vary considerably among studies. Sedated examina-

tions seem to be associated with less discomfort than unsedated examinations

[23,24]. Whether this is a true assessment of intra-procedure discomfort or

a reflection of an amnestic response after the administration of benzodiazepines

is difficult to determine. The majority of patients report no or mild discomfort

during unsedated sc-EGD, although nearly 10% admit to severe discomfort,

usually during insertion [6,25]. Some groups have reported increased symp-

toms, such as gagging and choking, with unsedated sc-EGD versus c-EGD


[7,9,18], whereas others have reported no difference [14]. The amount of pain

reported during unsedated sc-EGD also varies. When compared with sedated

c-EGD, Wilkens et al [9] found that unsedated sc-EGD patients did not report

increased pain.

The few studies comparing the tolerability of a transnasal versus transoral

approach to unsedated sc-EGD yield mixed results. Zaman et al [13] compared

29 patients undergoing transnasal sc-EGD with 35 patients undergoing transoral

sc-EGD. There was no difference in the endoscopist’s assessment of patient

comfort during the procedure. Patients completed a questionnaire after the pro-

cedure and indicated more pain during insertion with the transnasal approach as

compared with the transoral approach (P = 0.03). There were trends toward better

overall tolerance and willingness to undergo future unsedated procedures in the

transoral group, but these did not achieve statistical significance. In 170 Australian

patients randomized to transnasal versus transoral unsedated sc-EGD, there were

no differences in patient assessment of the overall tolerability or willingness to

repeat the examination [12]. Increased difficulty with transnasal insertion was

reported by the endoscopists (P = 0.007). Recently, Dumortier et al [15] reported

that 95% of 1033 French patients who successfully underwent unsedated small-

caliber transnasal EGD were willing to repeat it. Furthermore, 91% of the

377 patients who had previously undergone unsedated transoral EGD preferred

the transnasal route.

Although the majority of the literature suggests that unsedated endoscopy is not

as tolerable as sedated EGDs, many patients report a willingness to undergo an

unsedated examination in the future if medically indicated. The literature suggests

that smaller-caliber endoscopes are better tolerated by patients than larger-caliber

endoscopes. There are conflicting data on whether the transnasal versus transoral

route improves patient tolerance. A large percentage of eligible patients refuse

entry into studies of unsedated endoscopy, and the study populations are well

selected and are highly motivated. How these findings translate into the clinical

practice of upper endoscopy in the United States remains to be seen.

Factors contributing to success

To fully integrate unsedated endoscopy into daily practice, it is important to

know which patients are likely to tolerate an unsedated procedure. This area has

received only cursory attention in the literature. Smaller-caliber endoscopes are

better tolerated by unsedated patients than conventional instruments. An OD of

< 9 mm is associated with more completed examinations, less patient discomfort,

and a higher likelihood that the patient would undergo another unsedated

examination in the future [8,25]. In contrast, Catanzaro et al [17] reported better

patient tolerance with a 4.0-mm endoscope than with historical data from use with

a 3.1-mm endoscope. The reasons for this difference are not clear but may be

related to increased experience with ultrathin instruments in the latter trial.

The influence of gender on tolerability is controversial. Many authors cite

female gender as a factor predictive of not tolerating an unsedated endoscopy


[15,24], although this is not universal [6,7,23,25]. Older age is associated with

better tolerance [4,6,24], as is decreased pharyngeal sensitivity. In a study of

268 Canadian patients undergoing unsedated EGD with a standard instrument

(OD 9.8 mm), only advanced age and decreased pharyngeal sensitivity were in-

dependent predictors of success [4].

Pre-procedure anxiety level has also been reported to be a predictor of tolera-

bility. A number of investigators have assessed pre-procedure anxiety, usually

with a modified visual analog scale. High pre-procedure anxiety is associated with

poor tolerance of an unsedated EGD in some series [24] but not in others [25].

Abraham et al [4] assessed this factor with a scale of generalized anxiety and

depression and found that a history of rarely feeling panic was associated with

greater tolerance of unsedated endoscopy. High pre-procedure anxiety was related

to higher intra-procedure pain scores in the only study to assess this parameter on

US subjects [21].

Safety

The most common complications in traditional endoscopy are cardiopulmo-

nary complications related to sedation. An ASGE/FDA collaborative study of

21,011 procedures showed the incidence of serious cardiopulmonary complica-

tions to be 5.4/1000 cases and the incidence of death to be 0.3/1000 cases [3]. One

of the main arguments for pursuing unsedated endoscopy is the assumption that

the absence of sedation results in fewer procedure-related complications. Given

this low complication rate, an extremely large population needs to be studied to

determine whether unsedated EGD is safer than a sedated examination.

The current literature is limited to small studies that describe a serious com-

plication rate of 0% to 1.6% in unsedated EGD [7,9,11,13,18,21,23]. In a small

study randomizing patients to transoral versus transnasal sc-EGD, one patient in

the transnasal group had severe gagging, and the procedure was terminated [13].

The patient developed facial swelling several hours after the procedure, and an

esophageal perforation was suspected by water-soluble contrast x-ray; this was not

confirmed on surgical exploration. Craig et al [12] reported on 170 patients who

underwent transoral (n = 86) or transnasal (n = 84) sc-EGD [12]. No complications

occurred in the transoral group. In the transnasal group, 16 (22%) cases of epi-

staxis occurred. All cases were self-limited and did not require specific interven-

tion, although in one case the bleeding lasted 8 hours. Two patients in the

transnasal group also required supplemental oxygen for transient oxygen desatu-

ration. The largest prospective study of unsedated transnasal EGD (1100 patients)

revealed epistaxis in 2.3%, nasal pain in 1.6%, and vasovagal reactions in 0.3%

of [15].

Although the complication rate of unsedated endoscopy seems to be lower

than that of standard endoscopy, most of current literature is limited to small

series of less than 100 patients and is thus inadequately powered. Epistaxis is not

uncommon after a transnasal sc-EGD; all reports to date suggest that this is a self-

limited problem, and major complications related to epistaxis have not been


reported. Whether or not an episode of epistaxis alters patient acceptance or

tolerance of a transnasal approach has not been formally evaluated. Finally,

there is at least one report of a possible esophageal perforation related to severe

gagging during unsedated endoscopy. Although this does not seem to be a com-

mon occurrence, larger studies are needed to determine the true rate of this

important complication.

Cost-effectiveness

Financial savings may be the major impetus to widespread adoption of

unsedated endoscopy. Much of the cost incurred during endoscopy is related to

cardiopulmonary monitoring during and after sedation; elimination of sedation

would therefore reduce costs substantially. The overall costs will be reduced only

if the vast majority of unsedated cases are adequate, feasible, and tolerable.

Having to repeat procedures with sedation negates the cost-saving benefits of

unsedated endoscopy.

Despite the importance of this issue, the impact of unsedated endoscopy on the

overall cost of EGD has been addressed in only a few small studies. Gorelick et al

[5] assessed the potential cost savings associated with unsedated small-caliber

EGD. Sixteen patients undergoing unsedated sc-EGD were matched for age,

gender, and indication with a control group of 16 patients who underwent cEGD.

The unsedated sc-EGD patients had a mean procedure time of 5.2 versus

13.5 minutes in the cEGD group (P < 0.001). The mean cost of sc-EGD was

$462, significantly lower than $587 for a sedated examination (P < 0.001). These

figures do include physician fees. The authors cite other potential areas for saving

that were not factored into their analysis: lack of need for a driver, less time off

work, and the possibility of using medical assistants rather than registered nurses

to assist with the procedure. Bampton et al [26] compared unsedated transnasal

EGD to sedated transoral EGD. Although the mean procedure time was not dif-

ferent between the two groups, the recovery time was 7 minutes for the unsedated

transnasal examination and 37 minutes for the sedated EGD. They concluded that

consumable costs were reduced by 65% in the unsedated group and that

pharmaceutical costs were reduced by 92%. Other authors, without performing

a formal cost analysis, have suggested that unsedated procedures could be

performed by a primary care physician in the office setting, thereby increasing

access and decreasing costs associated with EGD [9]. Nietert et al [27] recently

published a cost-benefit analysis of sc-EGD in patients with GERD. They

calculated a median cost of $97 for unsedated sc-EGD versus $346 for conven-

tional sedated endoscopy. Assuming a prevalence of 3% for undiagnosed Barrett’s

esophagus in a patient with GERD, they concluded that sc-EGD was more cost-

effective than no screening or conventional sedated EGD, with a cost of $49,787

per quality adjusted life-year saved.

The issue of cost savings in unsedated endoscopy needs to be formally

addressed in large population-based studies to determine the effects of variations

in patient population, acceptance, completion rates, and diagnostic accuracy.


Unsedated colonoscopy

Although uncommon in the United States, unsedated colonoscopy is routinely

performed in Europe and Asia. A number of studies have demonstrated good

results with unsedated colonoscopy, although the data are limited to small, un-

controlled series. The relevant literature is reviewed below.

As-needed sedation may be a viable alternative to routinely given sedation in

colonoscopy. In a nonrandomized German study of 100 patients referred for

colonoscopy, a complete unsedated examination was achieved in 95% [28]. Five

percent of patients requested sedation due to discomfort. This group was com-

pared with 100 patients undergoing barium enema. Intraprocedure discomfort in

the unsedated colonoscopy group was reported as mild and not significantly dif-

ferent from the barium enema group. Eighty-seven percent of all patients under-

going colonoscopy were willing to have unsedated colonoscopy in the future if

medically indicated. This study suggests that colonoscopy may be performed with

sedation given on an as-needed basis only and that the majority of patients do not

need sedation. It also suggests that unsedated colonoscopy is not associated with

significantly more discomfort than barium enema, an examination in which seda-

tion is not routinely given. A randomized study in Finland divided 180 patients

scheduled for diagnostic colonoscopy into three groups: intravenous midazolam,

intravenous saline (placebo), or no intravenous injections (control) [29]. Although

the midazolam group rated the examination as less difficult than the saline group,

there was no difference between the midazolam group and the control group. The

authors concluded that routinely administered sedation does not increase patient

tolerance during colonoscopy. In a United States center, Rex et al [30] randomized

70 patients to receive sedation on an as-needed basis versus routine sedation. To-

tal colonoscopy was achieved without sedation in 94% of the sedation as-needed

group. Mean pain scores were higher in the sedation as-needed group when

compared with the routine sedation group. In the sedation as-needed group, 31 of

34 patients were ‘‘very satisfied,’’ and three patients were ‘‘somewhat satisfied.’’

Seventeen patients who could not be included in the trial because they requested

unsedated examinations had complete colonoscopies, and all reported that they

were ‘‘very satisfied.’’

Four hundred fifty-one patients in Norway were studied as they underwent

screening colonoscopy without sedation [31]. The cecal intubation rate was only

82%. The majority of patients later reported that they did not find the examination

uncomfortable, and 90% said they would be willing to have it performed in the

future. Although most patients had a favorable experience, the relatively low cecal

intubation rate raises the concern of decreased accuracy in unsedated colonoscopy.

A Japanese study compared the efficacy of the variable-stiffness colonoscope

(VC) with the conventional colonoscope (CC) [32]. Four hundred sixty-seven

patients were randomized to undergo unsedated VC or unsedated CC. The per-

centages of completed procedures with VC and CC were 99% and 98%,

respectively, and the times for cecal intubation were 9.8 and 10.6 minutes, re-

spectively. The percentage of patients rating the procedure as moderately or


severely painful was significantly lower with VC as compared with CC (19%

versus 40%, P < 0.01)

Patient attitudes may be the greatest deterrent to more widespread practice of

unsedated colonoscopy. Early et al [33] surveyed 434 patients before and after

colonoscopy regarding their willingness to undergo the procedure without se-

dation. On the pre-procedure questionnaire, only 17% of patients stated they

would be willing to have an unsedated examination. This increased to 22.6%

on the post-procedure questionnaire. Male gender, higher educational level, and

low procedural-related anxiety were predictors of willingness to undergo unse-

dated colonoscopy. Rex et al [30] found that male gender, increasing age, and

absence of abdominal pain were associated with willingness to try unsedated

colonoscopy [30].

In summary, the scant amount of literature on unsedated colonoscopy make it

difficult to fully assess the feasibility and acceptability of this procedure. Current

literature suggests that unsedated colonoscopy can be technically feasible but that

patient attitudes may prevent the procedure from achieving widespread accept-

ance. Large randomized controlled studies are needed in the United States to

determine if unsedated colonoscopy has a role in daily practice. In particular,

studies are required to assess the adequacy of the examinations, the procedure

duration, and potential cost savings.

Summary

Unsedated endoscopy will likely play an increasingly important role in the

daily practice of GI endoscopy. Although there is adequate evidence that un-

sedated endoscopy is technically feasible in selected patient populations, there are

a number of obstacles preventing its widespread adoption. Small-caliber endos-

copy is not as accurate as conventional EGD. This may be remedied as improve-

ments in endoscope technology emerge. Many patients refuse to consider an

unsedated examination, and those who do participate report more symptoms of

discomfort than patients undergoing conventional endoscopy. Whether patients

will accept mild discomfort in exchange for substantial cost savings has not been

evaluated. Finally, although unsedated endoscopy seems to have a low compli-

cation rate, its safety has not been formally addressed in large studies. Large,

randomized, controlled studies are needed to better determine the role of un-

sedated small-caliber endoscopy in daily practice. Unsedated colonoscopy may

follow the footsteps of unsedated upper endoscopy with even more obstacles to

overcome before its widespread application.

References

[1] Hedenbro JL, Lindblom A. Patient attitudes to sedation for diagnostic upper endoscopy. Scand J

Gastroenterol 1991;26:1115–20.


[2] Waye J. Worldwide use of sedation and analgesia for upper intestinal endoscopy. Gastrointest

Endosc 1999;50:888–91.

[3] Arrowsmith JB, Gerstman BB, Fleischer DE, Benjamin SB. Results from the American Society

for Gastrointestinal Endoscopy/US Food and Drug Administration collaborative study on com-

plication rates and drug use during gastrointestinal endoscopy. Gastrointest Endosc 1991;37:

421–7.

[4] Abraham N, Barkun A, LaRocque M, Fallone C, Mayrand S, Baffis V, et al. Predicting which

patients can undergo upper endoscopy comfortably without conscious sedation. Gastrointest

Endosc 2002;56:180–9.

[5] Gorelick AB, Inadomi JM, Barnett JL. Unsedated small-caliber esophagogastroduodenoscopy

(EGD): less expensive and less time consuming than conventional EGD. J Clin Gastroenterol

2001;33:210–4.

[6] Zaman A, Hapke R, Sahagun G, Katon RM. Unsedated peroral endoscopy with a video ultrathin

endoscope: patient acceptance, tolerance, and diagnostic accuracy. Am J Gastroenterol 1998;93:

1260–3.

[7] Sorbi D, Gostout CJ, Henry J, Lindor KD. Unsedated small-caliber esophagogastroduodenoscopy

(EGD) versus conventional EGD: a comparative study. Gastroenterology 1999;117:1301–7.

[8] Mulcahy HE, Riches A, Kiely M, Farthing MJG, Fairclough PD. A prospective controlled trial

of an ultrathin versus a conventional endoscope in unsedated upper gastrointestinal endoscopy.

Endoscopy 2001;33:311–6.

[9] Wilkins T, Brewster A, Lammers J. Comparison of thin versus standard esophagogastroduodeno-

scopy. J Fam Pract 2002;51:625–9.

[10] Madhotra R, Mokhashi M, Willner I, Hawes RH, Reuben A. Prospective evaluation of a 3.1-mm

battery-powered esophagoscope in screening for esophageal varices in cirrhotic patients. Am J

Gastroenerol 2003;98:807–12.

[11] Campo R, Montserrat A, Brullet E. Transnasal gastroscopy compared to conventional gastros-

copy: a randomized study of feasibility, safety, and tolerance. Endoscopy 1998;30:448–52.

[12] Craig A, Hanlon J, Dent J, Schoeman M. A comparison of transnasal and transoral endoscopy

with small-diameter endoscopes in unsedated patients. Gastrointest Endosc 1999;49:292–6.

[13] Zaman A, Hahn M, Hapke R, Knigge K, Fennerty MB, Katon RM. A randomized trial of peroral

versus transnasal unsedated endoscopy using an ultrathin videoendoscope. Gastrointest Endosc

1999;49:279–84.

[14] Saeian K, Staff D, Knox J, Binion D, Townsend W, Dua K, et al. Unsedated transnasal endos-

copy: a new technique for accurately detecting and grading esophageal varices in cirrhotic

patients. Am J Gastroenterol 2002;97:2246–9.

[15] Dumortier J, Napoleon B, Hedelius F, Pellissier P, Leprince E, Pujol B, et al. Unsedated trans-

nasal EGD in daily practice: results with 1100 consecutive patients. Gastrointest Endosc 2003;

57:198–204.

[16] Wildi SM, Wallace MB, Glenn TF, Mokhashi MS, Kim CY, Hawes RH. Accuracy of esophagos-

copy performed by a non-physician endoscopist with a 4-mm diameter battery-powered endo-

scope. Gastrointest Endosc 2003;57:305–10.

[17] Catanzaro A, Faulx A, Isenberg GA, Wong RCK, Cooper G, Sivak MV, et al. Prospective

evaluation of 4-mm diameter endoscopes for esophagoscopy in sedated and unsedated patients.

Gastrointest Endosc 2003;57:300–4.

[18] Catanzaro A, Faulx A, Pfau PR, Cooper G, Isenberg G, Wong RCK, et al. Accuracy of a narrow-

diameter battery-powered endoscope in sedated and unsedated patients. Gastrointest Endosc

2002;55:484–7.

[19] Dean R, Dua K, Massey B, Berger W, Hogan WJ, Shaker R. A comparative study of unsedated

transnasal esophagogastroduodenoscopy and conventional EGD. Gastrointest Endosc 1996;44:

422–4.

[20] Saeian K, Staff DM, Vasilopoulos S, Townsend WF, Almagro UA, Komorowski RA, et al.

Unsedated transnasal endoscopy accurately detects Barrett’s metaplasia and dysplasia. Gastro-

intest Endosc 2002;56:472–8.


[21] Faulx AL, Catanzaro A, Zyzanski S, Cooper GS, Pfau PR, Isenberg G, et al. Patient tolerance

and acceptance of unsedated ultrathin esophagoscopy. Gastrointest Endosc 2002;55:620–3.

[22] Solomon SA, Kajla VK, Banerjee AK. Can the elderly tolerate endoscopy without sedation? J R

Coll Physicians Lond 1994;28:407–10.

[23] Fisher NC, Bailey S, Gibson JA. A prospective, randomized controlled trial of sedation vs no

sedation in outpatient diagnostic upper gastrointestinal endoscopy. Endoscopy 1998;30:21–4.

[24] Froehlich F, Schwizer W, Thorens J, Kohler M, Gonvers JJ, Fried M. Conscious sedation for

gastroscopy: patient tolerance and cardiorespiratory parameters. Gastroenterology 1995;108:

697–704.

[25] Mulcahy HE, Kelly P, Banks MR, Connor P, Patchet SE, Farthing MJG, et al. Factors associated

with tolerance to, and discomfort with, unsedated diagnostic gastroscopy. Scand J Gastroenterol

2001;36(12):1352–7.

[26] Bampton PA, Reid DP, Johnson RD, Fitch RJ, Dent J. A comparison of transnasal and transoral

oesophagogastroduodenoscopy. J Gastroenterol Hepatol 1998;13:579–84.

[27] Nietert PJ, Silverstein MD, Mokhashi MS, Kim CY, Glelnn TF, Marsi VA, et al. Cost effective-

ness of screening a population with chronic gastroesophageal reflux. Gastrointest Endosc 2003;

57:311–8.

[28] Eckardt VF, Kanzler G, Willems D, Eckardt AJ, Bernhard G. Colonoscopy without premedi-

cation versus barium enema: a comparison of patient discomfort. Gastrointest Endosc 1996;44:

177–80.

[29] Ristikankare M, Hartikainen J, Heikkinen M, Janatuinen E, Julkunen R. Is routinely given

conscious sedation of benefit during colonoscopy? Gastrointest Endosc 1999;49:566–72.

[30] Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associ-

ated clinical factors and results of a randomized controlled trial. Gastrointest Endosc 1999;49:

554–9.

[31] Thiis-Evensen E, Hoff GS, Sauar J, Vatn MH. Patient tolerance of colonoscopy without sedation

during screening examination for colorectal polyps. Gastrointest Endosc 2000;52:606–10.

[32] Yoshikawa I, Honda H, Nagata K, Kanda K, Yamasaki T, Kume K, et al. Variable stiffness

colonoscopies are associated with less pain during colonoscopy in unsedated patients. Am J

Gastroenterol 2002;97:3052–5.

[33] Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing

colonoscopy without sedation. Am J Gastroenterol 1999;94:1862–5.

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Unsedated endoscopy

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