Non-anesthesiologist Administered Propofol Sedation for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Digestive System Diseases Colonoscopy Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Non-anesthesiologist propofol sedation

Bolus propofol sedation by non-anesthesiologist

Group Type EXPERIMENTAL

Non-anesthesiologist propofol sedation

Intervention Type DRUG

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

Colonoscopy

Intervention Type PROCEDURE

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

Anesthesiologist administered propofol

Propofol sedation administered by an anesthesiologist

Group Type ACTIVE_COMPARATOR

Propofol sedation administered by an anesthesiologist

Intervention Type DRUG

Propofol sedation by an anesthesiologist

Colonoscopy

Intervention Type PROCEDURE

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

Interventions

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Non-anesthesiologist propofol sedation

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

Intervention Type DRUG

Propofol sedation administered by an anesthesiologist

Propofol sedation by an anesthesiologist

Intervention Type DRUG

Colonoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes