Endoscopy 2016; 48(08): 747-753
DOI: 10.1055/s-0042-105560
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Alexandre Oliveira Ferreira
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Joana Torres
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Elidio Barjas
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Joana Nunes
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Luisa Glória
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Rosa Ferreira
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Manuel Rocha
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Sónia Pereira
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Sofia Dias
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Antonio Alberto Santos
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
,
Marília Cravo
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal
› Author Affiliations
Further Information

Publication History

submitted 02 November 2015

accepted after revision 10 March 2016

Publication Date:
21 April 2016 (online)

Preview

Background and study aims: 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.

Patients and methods: 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.

Results: 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.

Conclusions: NAAP is equivalent to anesthesiologist-administered sedation in the rate of adverse events in a low risk population.

Trial registration: ClinicalTrials.gov (NCT02067065).