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


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.


BACKGROUND
ClinicalTrials.gov (NCT02067065).
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Alexandre Oliveira
AO
Ferreira
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Joana
J
Torres
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Elidio
E
Barjas
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Joana
J
Nunes
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Luisa
L
Glória
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Rosa
R
Ferreira
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Manuel
M
Rocha
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Sónia
S
Pereira
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Sofia
S
Dias
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Antonio Alberto
AA
Santos
Serviço de Gastrenterologia, Hospital Beatriz Ângelo, Loures, Portugal.
Marília
M
Cravo
D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D000776:Anesthesiology; D003113:Colonoscopy / Q000009:adverse effects / Q000592:standards; D054810:Deep Sedation / Q000009:adverse effects*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D017060:Patient Satisfaction; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects*; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D000078329:Workforce; D055815:Young Adult
D006993:Hypnotics and Sedatives; D015742:Propofol