Non-anesthesiologist administration of propofol sedation for colonoscopy is safe in low risk patients: results of a noninferiority randomized controlled trial.

Abstract

Propofol provides the best sedation in colonoscopy. The safety of non-anesthesiologist administration of propofol (NAAP) is still a matter of debate. The aim of the current study was to evaluate sedation safety, colonoscopy quality, and patient satisfaction with NAAP. The study was a single-blinded, noninferiority, randomized controlled trial comparing NAAP (Group A) with anesthesiologist-administered sedation (Group B) performed at a single academic institution. Patients (18 - 80 years) who underwent colonoscopy and were at low anesthetic risk (American Society of Anesthesiologists class I - II) were included. The primary end point was the incidence of adverse events. Secondary end points were propofol dose, patient satisfaction and pain, colonoscopy quality indicators, and procedure and recovery times. A total of 277 patients were included in the analysis. The incidence of adverse events was 39.3 % in Group A and 39.0 % in Group B (absolute difference - 0.3 %, 95 % confidence interval [CI] - 12.0 % to 11.4 %; P = 0.959). There were no sentinel adverse events. The following interventions (Group A vs. Group B) were necessary: atropine administration (0 % vs. 5.5 %; P = 0.004); airway repositioning (8.7 % vs. 4.7 %; P = 0.196); increased oxygen administration (6.7 % vs. 3.9 %; P = 0.317), and increased fluid rate (2.7 % vs. 0.8 %; P = 0.379). There were no differences in cecal intubation and adenoma detection rates. Recovery times were longer in Group B (58 ± 33 vs. 67 ± 29 minutes; P = 0.032). There were no differences in mean propofol dose, withdrawal time, painless colonoscopy, satisfaction, and amnesia. All but two patients (Group B) were willing to repeat the colonoscopy. NAAP is equivalent to anesthesiologist-administered sedation in the rate of adverse events in a low risk population. ClinicalTrials.gov (NCT02067065).