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