Effect of the midazolam added with propofol-based sedation in
esophagogastroduodenoscopy: A randomized trial
Eun Hye Kim, Jun Chul Park, Sung Kwan Shin, Yong Chan Lee and Sang Kil Lee
Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
endoscopy, midazolam, propofol, sedation.
Accepted for publication 12 October 2017.
Dr Sang Kil Lee, Department of Internal
Medicine, Yonsei University College of
Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul
Declaration of conflict of interest: The authors
declare that they have no conﬂict of interest.
Background and Aim: Although propofol has been widely used for sedation during
esophagogastroduodenoscopy (EGD), adverse events including hypoxia and hypotension
may be a concern in the propofol-based sedation. We aimed to analyze whether administra-
tion of midazolam would improve safety and efﬁcacy of propofol-based sedation in EGD.
Methods: One hundred twenty patients who were scheduled to undergo diagnostic EGD
were randomly assigned to either midazolam plus propofol (MP) or propofol alone groups.
In the MP group, 2 mg of midazolam and 10 mg of propofol were given initially. In the
propofol alone group, 40–60 mg of propofol was given initially. In both groups, 20 mg
of propofol was given repeatedly to maintain moderate sedation as needed. Vital signs
including oxygen saturation were monitored every 2 min. After the patients fully recovered,
satisfaction score was investigated from endoscopists, nurses, and patients, respectively.
Results: The baseline characteristics did not differ between the MP and propofol alone
groups. The mean required doses of propofol was (mean ± standard deviation) 0.3 ± 0.3
and 0.8 ± 0.2 mg/kg in the MP and propofol alone groups, respectively (P < 0.001). In
addition, sedation-related adverse events and recovery time did not differ between the two
groups. The proportion of satisfactory did not differ between the two groups (MP vs
propofol alone; proportion; patient, 95.0% vs 93.3%, P > 0.999; endoscopist, 73.3% vs
80.0%, P=0.064; nurse, 73.3% vs 76.7%, P = 0.551).
Conclusion: Adding midazolam to propofol did not reduced the safety and efﬁcacy, and
sedation using propofol alone could be suitable for sedation during diagnostic EGD.
Sedation improves patient’s satisfaction with endoscopy and also
improves quality of the examination. Esophagogastroduodenoscopy
(EGD) is a diagnostic technique widely used in the world, and it is
more widely used as a screening apparatus of gastric cancer in the
East. The use of sedation for EGD varies from country to country
and even differs within the same country because of social, cultural,
economic, and regulatory inﬂuences.
Propofol is a short-acting sedative-hypnotic drug with a rapid
onset of action and rapid recovery proﬁle, and it is easy to use to
maintain a proper sedation level.
The onset of effect for
propofol is 0.5 to 1 min and the duration of effect is 4 to 8 min.
However, there are several adverse events, including respiratory
depression, hypotension, and pain on injection.
is resulted from decreased cardiac output and systemic vascular
resistance of propofol.
With overdosing, respiratory depression
generally precedes clinically signiﬁcant hypotension.
injection is reported by up to 30% of patients, especially when
receiving an intravenous bolus of propofol.
In addition, there
is no existing pharmacologic antagonist recovering from the
Midazolam is one of the benzodiazepines that have multiple
pharmacologic effects and facilitating sedation for endoscopy.
Benzodiazepines have anxiolytic, euphoriant, sedative-hypnotic,
amnestic (anterograde), anticonvulsant, and muscle-relaxing
Midazolam is the popular choice of drug for endos-
copy due to the shorter duration of its effect and its better pharma-
cokinetic proﬁle compared with the other benzodiazepines.
Additionally, midazolam has the antidote for recovering from the
Midazolam can be used in the propofol-based
sedation to reduce the propofol dose in order to reduce the risk
of adverse events caused by propofol.
Clinicians may favor such
a combined regimen (midazolam plus propofol) even in EGD;
however, safety and efﬁcacy of sedation via midazolam plus
propofol in EGD has not been evaluated. Because EGD does not
require long procedure time unlike colonoscopy, lasting sedative
effect of midazolam may be less useful in the EGD.
aimed to compare the safety and efﬁcacy of sedation between
midazolam plus propofol (MP) and propofol alone.
Patients. This was designed as a prospective, randomized-
controlled study. Patients who were scheduled for diagnostic
EGD were screened for enrollment, at Severance Hospital, Seoul,
Korea, between January 2013 and February 2015. Exclusion
criteria were as follows: age < 20 years; patients who did not
want sedation during endoscopic examination, those with known
Journal of Gastroenterology and Hepatology 33 (2018) 894–899
© 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd