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

Study Overview
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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.

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

Conditions
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Digestive System Diseases, Colonoscopy Sedation

Intervention / Treatment
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* Drug: Non-anesthesiologist propofol sedation
* Drug: Propofol sedation administered by an anesthesiologist
* Procedure: Colonoscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-anesthesiologist propofol administration, Sedation, Colonoscopy, Propofol