Official Title
Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
Phase
N/ALead Sponsor
Hospital Beatriz ÂngeloStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Digestive System Diseases Colonoscopy SedationIntervention/Treatment
propofol ...Study Participants
277Propofol 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.
Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy
Propofol sedation by an anesthesiologist
Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
Bolus propofol sedation by non-anesthesiologist
Propofol sedation administered by an anesthesiologist
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
