REVIEW ARTICLE

The Comparison of Midazolam and Propofol in

Gastrointestinal Endoscopy: A Systematic Review
and Meta-analysis
Rongzan Zhang, PhD, Quan Lu, MD, and Younong Wu, MD

The most common sedative regimens used for gastro-

Introduction: Midazolam and propofol are both used for sedation in intestinal endoscopy include midazolam or propofol alone
gastrointestinal endoscopy. We conducted a systematic review and with or without opioids.8,9 Midazolam has the advantages
meta-analysis to compare the efficacy and safety of midazolam and of rapid onset and potent amnestic properties superior to the
propofol in gastrointestinal endoscopy.
older benzodiazepines, but it is limited by the prolonged
Materials and Methods: PubMed, EMbase, Web of science, half-life in patients with liver failure.10,11 The hypnotic agent
EBSCO, and Cochrane library databases were systematically propofol is initially redistributed to adipose tissue, and its
searched. Randomized controlled trials assessing the effect of mid- plasma concentration is rapidly reduced with short duration
azolam versus propofol on sedation in gastrointestinal endoscopy of action. Propofol is metabolized rapidly in the liver and
are included. Two investigators have independently searched for excreted by the kidney. Propofol serves as an alternative to
articles, extracted data, and assessed the quality of included studies.
This meta-analysis was performed using the random-effect model.
midazolam in patients with impaired hepatic or renal
function because of no requirement of dose adjustment.12,13
Results: Five randomized controlled trials involving 552 patients Several trials have compared the efficacy and safety of
were included in the meta-analysis. Overall, compared with midazolam and propofol for the sedation of patients
midazolam sedation during gastrointestinal endoscopy, propofol undergoing gastrointestinal endoscopy.14,15 Propofol is
sedation results in higher endoscopist satisfaction scores during reported to result in shorter discharge time, higher endo-
gastrointestinal endoscopy than midazolam [standard mean differ-
ence (Std. MD) = −0.71; 95% confidence interval (CI) = −1.05 to
scopist satisfaction, and patient satisfaction than midazolam
−0.37; P < 0.0001), but the comparison shows no remarkable during colonoscopy and upper gastrointestinal endoscopy.16
influence on patient satisfaction scores between midazolam and In contrast to this promising finding, however, some rele-
propofol (Std. MD = −0.34; 95% CI = −0.88 to 0.20; P = 0.21), vant randomized controlled trials (RCTs) show that there
procedure time (Std. MD = 0.14; 95% CI = −0.13 to 0.42; P = 0.31), are no significant differences of patient satisfaction and
hypoxia [risk ratio (RR) = 0.86; 95% CI = 0.53-1.38; P = 0.53), and procedure time between propofol and midazolam for gas-
bradycardia (RR = 1.05; 95% CI = 0.54-2.06; P = 0.89). In addition, trointestinal endoscopy.16,17 Considering these inconsistent
propofol shows higher incidence of hypotension than midazolam effects, we have therefore conducted a systematic review and
(RR = 0.58; 95% CI = 0.34-0.99; P = 0.04). meta-analysis of RCTs to compare the efficacy and safety of
Conclusions: When compared with midazolam sedation for gastro- propofol and midazolam for gastrointestinal endoscopy.
intestinal endoscopy, propofol sedation results in higher endoscopist
satisfaction scores, but may increase the incidence of hypotension.
MATERIALS AND METHODS
Key Words: midazolam, propofol, gastrointestinal endoscopy, This systematic review and meta-analysis was conducted
randomized controlled trials, meta-analysis according to the guidance of the Preferred Reporting Items
(Surg Laparosc Endosc Percutan Tech 2018;00:000–000)

S everal anesthesiological strategies have been developed to

provide optimal sedation for patients undergoing gastro-
intestinal endoscopy.1 Optimal sedation aims to improve
patient comfort and safety.2–4 Sedation is widely accepted
during gastrointestinal endoscopy, but the appropriate level
of sedation in this setting has not been established.5,6
Moderate sedation during gastrointestinal endoscopy is
commonly provided by intravenous opioid and/or benzodia-
zepine boluses. Propofol introduction has emerged as an
increasingly important approach for patients’ sedation.7

Received for publication December 20, 2017; accepted January 18,

2018.
From the Department of Anesthesiology, Fenghua People’s Hospital,
Ningbo, Zhejiang, China.
The authors declare no conflicts of interest.
Reprints: Rongzan Zhang, PhD, No. 79 Xinming Road, Fenghua City,
Ningbo, Zhejiang 315000, China (e-mail: fhhmj001@126). FIGURE 1. Flow diagram of study searching and selection proc-
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. ess. RCT indicates randomized controlled trial.

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 Zhang et al Surg Laparosc Endosc Percutan Tech  Volume 00, Number 00, ’’ 2018

for Systematic Reviews and Meta-analysis statement18 and Data Extraction and Outcome Measures
the Cochrane Handbook for Systematic Reviews of Inter- The following information was extracted for the
ventions.19 No ethical approval and patient consent were included RCTs: first author, publication year, sample size,
required, because all analyses were based on previous pub- sex, age, body mass index, and baseline characteristics of
lished studies. patients. The author was contacted to acquire the data when
necessary. The primary outcomes were endoscopist sat-
Literature Search and Selection Criteria isfaction scores and patient satisfaction scores. Secondary
PubMed, EMbase, Web of science, EBSCO, and the outcomes included procedure time, hypotension, hypoxia,
Cochrane library were systematically searched from incep- and bradycardia.
tion to December 2017, with the following keywords:
midazolam, propofol, and gastrointestinal endoscopy or Quality Assessment in Individual Studies
colonoscopy or gastric endoscopy. To include additional The Jadad Scale was used to evaluate the method-
eligible studies, the reference lists of retrieved studies and ological quality of each RCT included in this meta-
relevant reviews were also hand-searched, and the process analysis.20 This scale consists of 3 evaluation elements:
above was performed repeatedly until no further article randomization (0 to 2 points), blinding (0 to 2 points), and
was identified. Conference abstracts meeting the inclusion dropouts and withdrawals (0 to 1 points). One point would
criteria were also included. be allocated to each element if they had been mentioned in
The inclusion criteria were as follows: (1) study pop- the article, and another 1 point would be given if the
ulation consisted of patients undergoing gastrointestinal methods of randomization and/or blinding had been
endoscopy; (2) intervention sedation was midazolam versus detailed and appropriately described. If the methods of
propofol; and (3) the study design was RCT. Cirrhotic randomization and/or blinding were inappropriate, or
patients or patients with age below 18 years were excluded. dropouts and withdrawals had not been recorded, then 1

TABLE 1. Characteristics of Included Studies

Midazolam Group

Body Mass ASA

Male Index Class 1
No. References No. Age (y) (n) (kg/m2) (n) Methods
1 Ominami 66 70.1 ± 8.8 54 22.4 ± 3.3 7 An initial bolus of 3-4 mg of
et al17 midazolam, and the
increments of 2 mg until
RSS 5-6 for endoscopic
submucosal dissection for
esophageal squamous cell
carcinoma
2 Fanti et al16 35 52.3 ± 18.1 in 20 in 23.2 ± 4 in 16 in Fentanyl (1 μg/kg) +
EGD, EGD, EGD, EGD, midazolam (0.03-0.04 mg/
58.6 ± 11.6 in 20 in 23.2 ± 4.5 in 19 in kg) or midazolam only for
CS CS CS CS gastrointestinal
endoscopy
3 Lera dos 100 52.14 ± 15.01 34 25.91 ± 4.54 63 Initial dose of 2-5 mg
Santos et al22 midazolam, 0.5-1.0 mg
every 2-3 min, up to a
maximum cumulative
dose of 10 mg or 0.1 mg/
kg of body weight for
maintenance + fentanyl
for upper gastrointestinal
endoscopy
4 Meining 30 57, median 16 25.4, median 0 An initial dose of 1-2 mg,
et al23 1-2 mg boluses given until
the patient reached a state
of conscious sedation or
until a maximum dosage
of 5 mg for upper
gastrointestinal
endoscopy
5 Carlsson and 45 43 ± 13 21 — — Initial dose of 0.06 mg/kg
Grattidge24 midazolam, followed by
repeat doses of 50% of the
initial dose, as required
for upper gastrointestinal
endoscopy
ASA indicates American Society of Anesthesiologists risk class; CS, colonoscopy; EGD, upper endoscopy; RSS, Ramsay Sedation Score.

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 Surg Laparosc Endosc Percutan Tech  Volume 00, Number 00, ’’ 2018 Comparison of Midazolam and Propofol in GE

point was deducted. The score of the Jadad Scale varies > 50% indicates significant heterogeneity. Sensitivity anal-
from 0 to 5 points. An article with a Jadad score ≤ 2 was ysis was performed to detect the influence of a single study
considered to be of low quality. If the Jadad score was ≥ 3, on the overall estimate by omitting 1 study in turn when
the study was thought to be of high quality.21 necessary. Owing to the limited number (< 10) of included
studies, publication bias was not assessed. P-value <0.05 in
Statistical Analysis 2-tailed tests was considered statistically significant. All
Standard mean differences (Std. MDs) with 95% con- statistical analyses were performed with Review Manager
fidence intervals (CIs) for continuous outcomes (endoscopist Version 5.3 (The Cochrane Collaboration, Software
satisfaction scores, patient satisfaction scores, and procedure Update, Oxford, UK).
time) and risk ratios (RRs) with 95% CIs for dichotomous
outcomes (hypotension, hypoxia, and bradycardia) were
used to estimate the pooled effects. All meta-analyses were RESULTS
performed using random-effects models with DerSimonian
and Laird weights. Heterogeneity was tested using the Literature Search, Study Characteristics, and
Cochrane Q statistic (P < 0.1) and quantified with the I2 Quality Assessment
statistic, which describes the variation of effect size that is The flow chart for the selection process and detailed
attributable to heterogeneity across studies. An I2 value identification are presented in Figure 1. Seven hundred fifty

TABLE 1. Continued
Propofol Group
Body Mass ASA
Male Index Class 1 Jada
No. Age (y) (n) (kg/m2) (n) Methods Scores
66 69.5 ± 8.2 52 22.0 ± 3.0 7 1% propofol 4
administered
continuously for
endoscopic
submucosal
dissection for
esophageal squamous
cell carcinoma
35 47.8 ± 17.5 in 22 in 24.3 ± 5 in 18 in Fentanyl (1 μg/kg) + 5
EGD, EGD, EGD, EGD, propofol Target
57.2 ± 13.8 in 22 in 25.4 ± 6.4 in 20 in Controlled Infusion
CS CS CS CS (1.2-1.6 μg/ml) or
propofol target
controlled infusion
only for
gastrointestinal
endoscopy
100 54.40 ± 15.44 29 27.39 ± 6.59 55 Initial dose of 0.25- 4
0.5 mg/kg propofol,
10-20 mg bolus at 60
s intervals for
maintenance +
fentanyl for upper
gastrointestinal
endoscopy
30 59, median 13 25.5, median 0 Initial dose 0.5-1 mg/kg, 3
further boluses of 10-
20 mg until conscious
sedation is achieved,
up to a maximum
dosage of 500 mg for
upper gastrointestinal
endoscopy
45 44 ± 12 18 — — Initial dose of 0. 6 mg/ 4
kg propofol, followed
by repeat doses of
50% of the initial
dose, as required for
upper gastrointestinal
endoscopy

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 Zhang et al Surg Laparosc Endosc Percutan Tech  Volume 00, Number 00, ’’ 2018

FIGURE 2. Forest plot for the meta-analysis of endoscopist satisfaction scores. CI indicates confidence interval.

FIGURE 3. Forest plot for the meta-analysis of patient satisfaction scores.

FIGURE 4. Forest plot for the meta-analysis of procedure time (min).

FIGURE 5. Forest plot for the meta-analysis of hypotension.

FIGURE 6. Forest plot for the meta-analysis of hypoxia.

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 Surg Laparosc Endosc Percutan Tech  Volume 00, Number 00, ’’ 2018 Comparison of Midazolam and Propofol in GE

FIGURE 7. Forest plot for the meta-analysis of bradycardia.

publications were identified through the initial search of MD = 0.14; 95% CI = −0.13 to 0.42; P = 0.31; Fig. 4). Pro-
databases. Ultimately, 5 RCTs were included in the meta- pofol is found to have higher incidence of hypotension than
analysis.16,17,22–24 midazolam (RR = 0.58; 95% CI = 0.34-0.99; P = 0.04;
The baseline characteristics of the 5 eligible RCTs in the Fig. 5). In addition, there was no significant difference of
meta-analysis are summarized in Table 1. The 5 studies were hypoxia (RR = 0.86; 95% CI = 0.53-1.38; P = 0.53; Fig. 6)
published between 1995 and 2017, and sample sizes range from and bradycardia (RR = 1.05; 95% CI = 0.54-2.06; P = 0.89;
60 to 200 with a total of 552. There was similar age, male sex, Fig. 7) between the 2 groups.
body mass index, and American Society of Anesthesiologist
class 1 between 2 groups at baseline. Four included RCTs
involved upper gastrointestinal endoscopy,17,22–24 and 1 DISCUSSION
included RCT involved the upper gastrointestinal endoscopy Propofol serves as a pure hypnotic and lacks analgesic
and colonoscopy.16 One RCT reports the endoscopic sub- properties, and deep sedation is frequently required to avoid
mucosal dissection for esophageal squamous cell carcinoma.17 withdrawal responses during gastrointestinal endoscopy.7,25
Among the 5 RCTs, 3 studies reported the endoscopist Propofol plus an opioid are able to achieve balanced sedation
satisfaction scores and patient satisfaction scores,16,17,22 and allow moderate propofol sedation with optimal pain
2 studies reported the procedure time,16,17 3 studies reported control. Balanced fentanyl-propofol sedation is revealed to
hypotension,16,17,22 4 studies reported hypoxia,16,17,22,24 and 2 produce a significant reduction of propofol doses and
studies reported bradycardia.16,17 Jadad scores of the 6 included recovery time.26 Meperidine and propofol combination
studies varied from 3 to 5, and all 5 studies were considered to be results in less propofol to complete the procedure of colo-
high-quality ones according to quality assessment. noscopy than propofol alone.27 Our meta-analysis suggests
that compared with midazolam sedation (or with fentanyl)
Primary Outcomes: Endoscopist Satisfaction for gastrointestinal endoscopy, propofol sedation (or with
Scores and Patient Satisfaction Scores fentanyl) results in higher endoscopist satisfaction, but
Fanti 2015 represents the outcomes of upper gastro- demonstrates no significant influence on patient satisfaction
intestinal endoscopy, and Fanti2 represents the outcomes of and procedure time.
colonoscopy. These 2 outcomes were analyzed with the ran- With regard to sensitivity analysis, there was no significant
dom-effects model, and the pooled estimate of the 3 included heterogeneity for endoscopist satisfaction scores after excluding
RCTs suggest that propofol has higher endoscopist satisfaction the study conducted by Lera dos Santos and colleagues. How-
scores during gastrointestinal endoscopy than midazolam ever, significant heterogeneity was still observed for patient sat-
(Std. MD = −0.71; 95% CI = −1.05 to −0.37; P < 0.0001), with isfaction scores by omitting 1 study in turn for the sensitivity
significant heterogeneity among the studies (I2 = 66%, hetero- analysis. There may be several reasons to explain this. First, a
geneity P = 0.03) (Fig. 2). However, there is no statistical different degree of pain control is required between colonoscopy
significance of patient satisfaction scores between midazolam and upper gastrointestinal endoscopy, and different operation
and propofol (Std. MD = −0.34; 95% CI = −0.88 to 0.20; procedures and operators experience the need for varied pain
P = 0.21), with significant heterogeneity among the studies management. Second, the sedation selection was different,
(I2 = 87%, heterogeneity P < 0.0001) (Fig. 3). including pure propofol, and the combination of propofol and
fentanyl. Third, the detailed methods of administration and doses
Sensitivity Analysis of propofol and midazolam are different in the included RCTs.
Significant heterogeneity was observed among the included It is well known that propofol oversedation can cause
studies for endoscopist satisfaction scores and patient satisfaction apnea and arterial desaturation, and respiratory depression
scores. As shown in Figure 2, the study conducted by Lera dos is mainly caused by the administered dose of propofol.28,29
Santos and colleagues shows the results that are almost out of Propofol sedation leads to higher incidence of hypotension,
range of the others and probably contributes to the hetero- but similar hypoxia and bradycardia compared with mid-
geneity. After excluding this study, the results suggest that pro- azolam during gastrointestinal endoscopy, based on the
pofol still results in higher endoscopist satisfaction scores during results of our meta-analysis. Propofol combined with ben-
gastrointestinal endoscopy than midazolam (Std. MD = −0.88; zodiazepines/opioids may be preferable to obtain moderate
95% CI = −1.13 to −0.63; P < 0.00001), and no heterogeneity sedation, and has better patient cooperation, satisfaction,
was observed among the remaining studies. However, there is and shorter recovery time than propofol or benzodiazepines/
still significant heterogeneity of patient satisfaction scores when opioids alone during gastrointestinal endoscopy.30
performing sensitivity analysis by omitting 1 study in turn. However, adding analgesics to propofol is con-
troversial, because of the risks and benefits. Opioids are
Secondary Outcomes reported to improve the patient’s comfort and the operative
Midazolam demonstrates similar procedure time com- conditions, but delay the return to basal mental status,
pared with propofol in gastrointestinal endoscopy (Std. because of their longer duration of action.31 Administration

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 Zhang et al Surg Laparosc Endosc Percutan Tech  Volume 00, Number 00, ’’ 2018

of fentanyl may be beneficial only for colonoscopies after 13. Park CH, Han DS, Jeong JY, et al. Outcomes of propofol
comparing the different degree of pain between colonoscopy sedation during emergency endoscopy performed for upper
and upper gastrointestinal endoscopy.16 In colonoscopy gastrointestinal bleeding. Dig Dis Sci. 2016;61:825–834.
patients, the 3-minute interval between fentanyl and pro- 14. Sipe BW, Rex DK, Latinovich D, et al. Propofol versus
midazolam/meperidine for outpatient colonoscopy: administra-
pofol administration and the start of the procedure allows tion by nurses supervised by endoscopists. Gastrointest Endosc.
the prompt recognition of opioid effect and avoids propofol 2002;55:815–825.
overdosing. A pharmacokinetic model is applied in Target 15. Dewitt J, McGreevy K, Sherman S, et al. Nurse-administered
Controlled Infusion system to achieve and maintain an propofol sedation compared with midazolam and meperidine
operator-selected target plasma propofol concentration for EUS: a prospective, randomized trial. Gastrointest Endosc.
using variations of its infusion rate. However, this system 2008;68:499–509.
requires precise knowledge of therapeutic blood concen- 16. Fanti L, Gemma M, Agostoni M, et al. Target controlled
tration to warrant the correct sedation depth that is asso- infusion for non-anaesthesiologist propofol sedation during
ciated with the stimulation from the procedure and the gastrointestinal endoscopy: the first double blind randomized
controlled trial. Dig Liver Dis. 2015;47:566–571.
interaction with concomitantly administered drugs.32 17. Ominami M, Nagami Y, Shiba M, et al. Comparison of
Several limitations should be taken into account. First, propofol with midazolam in endoscopic submucosal dissection
our analysis is based on only 5 RCTs and 3 of them have a for esophageal squamous cell carcinoma: a randomized
relatively small sample size (n < 100). Overestimation of the controlled trial. J Gastroenterol. 2018;53:397–406.
treatment effect is more likely in smaller trials compared with 18. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items
larger samples. Upper gastrointestinal endoscopy and colo- for systematic reviews and meta-analyses: the PRISMA state-
noscopy are both included in the included RCTs. Next, there is ment. BMJ. 2009;339:b2535.
significant heterogeneity when performing sensitivity analysis, 19. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews
and it may be caused by the different degree of pain control, of Interventions Version 510. The Cochrane Collaboration; 2011.
20. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of
various operation procedures, detail of methods, and doses of reports of randomized clinical trials: Is blinding necessary?
propofol and midazolam, etc. Finally, some unpublished and Control Clin Trials. 1996;17:1–12.
missing data may lead to bias of the pooled effect. 21. Kjaergard LL, Villumsen J, Gluud C. Reported methodologic
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trials in meta-analyses. Ann Inter Med. 2001;135:982–989.
CONCLUSIONS 22. Lera dos Santos ME, Maluf-Filho F, Chaves DM, et al. Deep
Propofol sedation may have some advantages to mid- sedation during gastrointestinal endoscopy: propofol-fentanyl
azolam sedation during gastrointestinal endoscopy, and and midazolam-fentanyl regimens. World J Gastroenterol.
combination of propofol and opioids should be recom- 2013;19:3439–3446.
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sedation on the quality of upper gastrointestinal endoscopy: an
investigator-blinded, randomized study comparing propofol
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