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

October 8, 2015 updated by: Alexandre Ferreira, Hospital Beatriz Ângelo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Angelo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-anesthesiologist propofol sedation
Bolus propofol sedation by non-anesthesiologist
Drug: Non-anesthesiologist propofol sedation
Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy
Procedure: Colonoscopy
Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
Active Comparator: Anesthesiologist administered propofol
Propofol sedation administered by an anesthesiologist
Procedure: Colonoscopy
Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
Drug: Propofol sedation administered by an anesthesiologist
Propofol sedation by an anesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minor adverse events
Time Frame: During the sedation period
Minor adverse events as defined by the International Sedation Task Force, including peripheral O2 saturation between 75-90% for less than 60 seconds, apnea, airway obstruction, sedation failure, allergic reaction without anaphylaxis, convulsion, brady/tachycardia and hypo/hypertension (>25% change from baseline)
During the sedation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Propofol dosage
Time Frame: During the colonoscopy - an estimated mean time of 20 minutes
Total propofol dosage
During the colonoscopy - an estimated mean time of 20 minutes
Patient satisfaction
Time Frame: Before discharge - estimated mean recovery time of 1 hour
A 10 point visual scale on pain
Before discharge - estimated mean recovery time of 1 hour
colonoscopy quality indicators
Time Frame: During the procedure
Colonoscopy quality indicators: time to cecum, withdrawal time, adenoma detection rate
During the procedure
Patient satisfaction 2
Time Frame: Before discharge - estimated mean recovery time of 1 hour
A 5 point likert scale on patient satisfaction with the sedation
Before discharge - estimated mean recovery time of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Beatriz Ângelo

Investigators

  • Principal Investigator: Alexandre O Ferreira, MD, Hospital Beatriz Angelo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 16, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ColonPropo-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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