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Digestive System Diseases | Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial

Digestive System Diseases research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Digestive System Diseases

Colonoscopy Sedation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Non-anesthesiologist propofol sedationBolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy

Drug:Propofol sedation administered by an anesthesiologistPropofol sedation by an anesthesiologist

Procedure:ColonoscopyElective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Non-anesthesiologist propofol sedationBolus propofol sedation by non-anesthesiologist

Anesthesiologist administered propofolPropofol sedation administered by an anesthesiologist

Study Status

Completed

Start Date: January 2014

Completed Date: August 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Minor adverse events

Secondary Outcome: Propofol dosage

Study sponsors, principal investigator, and references

Principal Investigator: Alexandre O Ferreira, MD

Lead Sponsor: Hospital Beatriz Ângelo

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02067065

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.

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