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

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.

Conditions

• Digestive System Diseases
• Colonoscopy Sedation

Interventions

DRUG

Non-anesthesiologist propofol sedation

Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy

DRUG

Propofol sedation administered by an anesthesiologist

Propofol sedation by an anesthesiologist

PROCEDURE

Colonoscopy

Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated

Sponsors & Collaborators

• Hospital Beatriz Ângelo

  lead OTHER

Principal Investigators

• Alexandre O Ferreira, MD · Hospital Beatriz Ângelo

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2015-03-31

Completion

2015-08-31

Countries

• Portugal

Study Locations