Colonoscopy Sedation, Digestive System Diseases
Conditions
Keywords
Colonoscopy, Sedation, Propofol, Non-anesthesiologist propofol administration
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.
Interventions
DRUGNon-anesthesiologist propofol sedation
Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy
DRUGPropofol sedation administered by an anesthesiologist
Propofol sedation by an anesthesiologist
PROCEDUREColonoscopy
Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
Sponsors
Hospital Beatriz Ângelo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Portugal
Outcome results
None listed