Digestive System Diseases Clinical Trial
Official title:
Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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