Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Beatriz Ângelo
• Treatments: Propofol

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