Clinical trial NCT02067065: Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
Official title: Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive System Diseases
Colonoscopy Sedation
Keywords: Colonoscopy
Sedation
Propofol
Non-anesthesiologist propofol administration
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the administration of propofol by non-anesthesiologists, despite moderate quality evidence that support its' use.

There is only one small trial of a direct comparison of propofol sedation by anesthesiologists versus non-anesthesiologists.

Our aim is to compare the incidence of sedation related adverse events, the procedural quality indicators, times (onset, recovery, discharge) and patient satisfaction between non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist propofol sedation.

A randomized clinical trial with the incidence of sedation related minor adverse events as primary endpoint will be conducted. Secondary endpoints include procedure quality indicators, propofol dosage and patient satisfaction.

A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90% power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events incidence, estimated from our pilot experience. The sample size was adjusted for a 2% cross-over rate.

Informed and consenting patients undergoing colonoscopy examinations will be randomly assigned to one of two arms. One group will be sedated by an anesthesiologist according to a protocol of propofol mono-sedation. The other group will be sedated with propofol boluses, according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a 3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained in NAAP and exclusively dedicated to sedation and patient monitoring.


Eligibility criteria: Inclusion Criteria:

* Referred for elective colonoscopy as outpatients
* Must be able to provide the informed consent

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) class \>2
* Pregnant women
* Difficult airway predictors (more than 2 ou Mallampati \>3)
* Allergy to propofol or its' components
* IV drugs abuse

Primary outcomes:
measure: Minor adverse events
timeFrame: During the sedation period
Secondary outcomes:
measure: Propofol dosage
timeFrame: During the colonoscopy - an estimated mean time of 20 minutes
measure: Patient satisfaction
timeFrame: Before discharge - estimated mean recovery time of 1 hour
measure: colonoscopy quality indicators
timeFrame: During the procedure
measure: Patient satisfaction 2
timeFrame: Before discharge - estimated mean recovery time of 1 hour
Other outcomes:
Locations:
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
Study officials:
affiliation: Hospital Beatriz Ângelo
name: Alexandre O Ferreira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
citation: Dumonceau JM, Riphaus A, Beilenhoff U, Vilmann P, Hornslet P, Aparicio JR, Dinis-Ribeiro M, Giostra E, Ortmann M, Knape JT, Ladas S, Paspatis G, Ponsioen CY, Racz I, Wehrmann T, Walder B. European curriculum for sedation training in gastrointestinal endoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). Endoscopy. 2013 Jun;45(6):496-504. doi: 10.1055/s-0033-1344142. Epub 2013 May 23. No abstract available.
citation: Ferreira AO, Torres J, Barjas E, Nunes J, Gloria L, Ferreira R, Rocha M, Pereira S, Dias S, Santos AA, Cravo M. Non-anesthesiologist administration of propofol sedation for colonoscopy is safe in low risk patients: results of a noninferiority randomized controlled trial. Endoscopy. 2016 Aug;48(8):747-53. doi: 10.1055/s-0042-105560. Epub 2016 Apr 21.