Table 1. Studies of the safety and efficacy of propofol administered for sedation in adults and children by an anesthesiologist, nurse
anesthetist, or assisting physician not directly involved with the endoscopic procedures
Researcher(s) (Year),
Design
Sample, Setting, Methods
Results and Conclusions
Amornyotin et al.
Randomized controlled
170 adults; high risk patients were
The researchers concluded that in the
(2007), Thailand
trial (RCT)
excluded from both groups.
adult Thai population, sedated diagnostic

Control group (C) received topical
esophagogastroduodenoscopy (EGD) led
Country
Level II evidence
(Melynk & Fineout- pharyngeal anesthesia alone.
Overholt, 2005)
to increased patients’ and endoscopists’
Intervention group (I) received
satisfaction and increased patient
topical pharyngeal anesthesia and
willingness to repeat procedure in the
intravenous sedation with
future if needed.
midazolam maintained with
The researchers did not provide procedure
continuous propofol infusion.
times for either group, but did comment
that the control group (unsedated patients)
moved through the endoscopy unit faster.
Hypertension and tachycardia were the
most common complications in the
control group and hypotension was the
most common complication in the
intervention group. The severity of
complications was not reported.
Barbi et al. (2003), Italy
Prospective descriptive
1,059 invasive procedures in
Major desaturation requiring a short
study
children birth to 20 years of age
course of ventilation occurred 0.8%
 Level VI evidence
(i.e., colonoscopy; EGD; lumbar
children undergoing EGD, 0.3% children
(Melynk & Fineout-
puncture; bone marrow aspiration;
undergoing painful procedures, and 0%
Overholt, 2005)
liver, muscle or skin biopsy;
children undergoing colonoscopies.
arthrocentesis; intestinal washout;
Laryngospasm occurred in 2.1% children.
and paracentesis) performed in a
No children required intubation. The
pediatric ward of a tertiary-care
researchers concluded that the use of
pediatric teaching hospital.
propofol with concurrent oxygen
administration allowed sedations in
children with no significant complications
for colonoscopies and painful procedures;
however, the complications in children
undergoing EGD were too high for
recommending use of propofol for
sedation in a unit with residents in
attendance.
Disma et al. (2005),
Double-blind RCT
240 ASA class I –II children, 1-12
Five patients in Group P were treated with
Italy
 Level II evidence
years of age, undergoing
bag-and-mask ventilation for < 1 minute.
(Melynk & Fineout-
diagnostic EGD were given
Recovery time and discharge from the
Overholt, 2005)
midazolam as a premedication and
hospital were similar in the three groups.
then were randomly assigned to
There was a lower incidence of adverse
one of three groups—propofol
events in Group PM and in Group PF than
alone, three 1 mg/kg doses (Group
in Group P (p < 0.05). The researchers
P); same doses of propofol and
concluded that propofol in combination
fentanyl 1 mcg/kg (Group PF); or
with fentanyl or midazolam gives better
the same doses of propofol and
sedation and ease of endoscopy than
midazolam 0.1 mg/kg (Group
propofol alone.
PM). Additional doses of propofol
were given during the procedure in
all three groups as needed. All
medications were administered
and children were monitored by an
anesthetist. All children received 3
L/minute oxygen per nasal
cannula.
Fanti et al. (2004), Italy
Prospective descriptive
205 adults undergoing endoscopic
The quality of sedation was judged
study
retrograde
satisfactory for 98% by both the

Level VI evidence
cholangiopancreaticography
endoscopist and the nurse assistant.
(Melynk & Fineout-
(ERCP) were sedated by an
Hypoxia (oxygen saturation < 85%)
Overholt, 2005)
anesthesiologist using a propofol
occurred in 1.9% of ASA Class III or
target-controlled infusion system.
higher patients, responding to either
The target plasma concentration of
turning patient to the supine position to
propofol ranged from 2-5 mcg/mL. improve airway patency or manual
A bolus of fentanyl (50-100 mcg)
ventilation for a few minutes. Mean time
was administered if signs of
to discharge was 31 + 12 minutes post-
insufficient analgesia were
procedure. The researchers concluded that
observed at the maximum target
a target-controlled infusion system for
concentration of propofol allowed.
administration of propofol provides safe
and effective sedation during ERCP.
Khoshoo, Thoppil,
Two parts: retrospective
There were two groups: 155
The onset of sedation was faster (p < 0.01)
Landry, Brown, & Ross
descriptive study
consecutive children (0.2-17.7
and the length of the procedure and
(2003), United States
involving 200 children
years of age) underwent diagnostic
recovery was significantly shorter (p <
and a prospective RCT
EGD received sedation with
0.01) in the PM group in both the
involving 60 children.
propofol with or without bolus
retrospective and prospective parts of the
 Levels VI and II
premedication with midazolam
study. In the retrospective part of the
evidence,
(PM group); data were collected
study, an equal number of children in both
respectively
retrospectively in 125 and
groups required increased supplemental
(Melynk & Fineout-
prospectively in 30 children. 105
oxygen or transient use of bag-valve-mask
Overholt, 2005)
consecutive children received
ventilation. In the prospective part of the
sedation with bolus midazolam for
study, more children in the MM group
induction and maintenance as
required increased supplemental oxygen.
needed plus meperidine at
No child required bag-valve-mask
induction only (MM group); data
ventilation in the prospective part of the
were collected retrospectively in
study. The researchers concluded that
75 and prospectively in 30
propofol is safe and effective for
children.
facilitating diagnostic EGD in children.
All procedures occurred in the
pediatric intensive care unit with
the intensivist administering all
medications. All patients received
l L/minute of supplemental oxygen
via nasal cannula.
Seifert et al. (2000),
Double-blind RCT
239 adults, equally divided
During therapeutic endoscopy, sedation
Germany
 Level II evidence
between those undergoing
with midazolam and propofol requires a
(Melynk & Fineout-
therapeutic EGD and those
lower total dose of propofol, but otherwise
Overholt, 2005)
undergoing ERCP, were randomly
has no superior sedation efficacy and is
assigned to receive either propofol
associated with a slower post-procedure
alone (Group A) or midazolam and recovery than sedation with propofol
propofol (Group B).
alone. Anterograde amnesia for the
procedure was present for all cases.
Retrograde amnesia was present for ~
25% of cases in both groups.
Tosun et al. (2007),
Double-blind RCT;
Ninety ASA I-II children aged 1-
Sedation was achieved in all procedures,
Turkey

16 years old.
and all but one (due to laryngospasm) was
Level II evidence
(Melynk & Fineout- Propofol-ketamine (PK) compared
Overholt, 2005)
successfully performed. Major
with propofol-fentanyl (PF) for
desaturation (10 seconds of apnea or SaO2
sedation in children undergoing
< 85%), requiring a short course of
EGD.
ventilation using bag-and-mask with
Additional propofol (0.5-1 mg/kg)
supplemental oxygen, occurred in 0.8%
was administered when a child
children undergoing EGDs and 0.3%
showed discomfort in both groups.
undergoing colonoscopies. Laryngospasm
Supplemental oxygen 3-4
(stridor), requiring use of bag-and-mask
L/minute was given via nasal
with oxygen supplementation or
cannula in all children.
continuous positive airway pressure
ventilation, occurred in 2.1% of children
undergoing EGD. The researchers
concluded that both the PK and PF
combinations provided effective sedation
in children, but the PK combination
resulted in stable hemodynamics and
deeper sedation although more children
experienced side effects.
Vargo et al. (2002),
Double-blinded RCT
75 adults ASA Class I-III received
Adults receiving propofol had shorter
United States
 Level II evidence
either gastroenterologist-
recovery times (18.6 versus 70.5 minutes,
(Melynk & Fineout-
administered propofol or
p < 0.001) and a higher recovery of both
Overholt, 2005)
meperidine/midazolam for ERCP
baseline activity level and dietary intake
or endoscopic ultrasonography.
24 hours after the procedure (71% versus
Monitoring with capnography
43%, p = 0.028). If a registered nurse had
allowed for rapid titration of
administered the propofol, the cost would
propofol at the earliest signs or
have been $59.80 versus $66.80 for
respiratory depression.
meperidine and midazolam, making
Supplemental oxygen was not
propofol more cost effective. Thus, the
given routinely. A dedicated
researchers concluded that
gastroenterologist administered the gastroenterologist-administered propofol
bolus doses of sedation and
using monitoring with capnography is
monitored the patient.
similar to meperidine/midazolam for both
physiological outcomes and
patient/endoscopist satisfaction and leads
to significantly improved baseline activity
and food intake 24 hours later.