Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
- Conditions
- Colonoscopy SedationDigestive System Diseases
- Interventions
- Registration Number
- NCT02067065
- Lead Sponsor
- Hospital Beatriz Ângelo
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 277
- Referred for elective colonoscopy as outpatients
- Must be able to provide the informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-anesthesiologist propofol sedation Colonoscopy Bolus propofol sedation by non-anesthesiologist Anesthesiologist administered propofol Propofol sedation administered by an anesthesiologist Propofol sedation administered by an anesthesiologist Anesthesiologist administered propofol Colonoscopy Propofol sedation administered by an anesthesiologist Non-anesthesiologist propofol sedation Non-anesthesiologist propofol sedation Bolus propofol sedation by non-anesthesiologist
- Primary Outcome Measures
Name Time Method Minor adverse events 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)
- Secondary Outcome Measures
Name Time Method Propofol dosage During the colonoscopy - an estimated mean time of 20 minutes Total propofol dosage
Patient satisfaction Before discharge - estimated mean recovery time of 1 hour A 10 point visual scale on pain
colonoscopy quality indicators During the procedure Colonoscopy quality indicators: time to cecum, withdrawal time, adenoma detection rate
Patient satisfaction 2 Before discharge - estimated mean recovery time of 1 hour A 5 point likert scale on patient satisfaction with the sedation
Trial Locations
- Locations (1)
Hospital Beatriz Ângelo
🇵🇹Loures, Portugal