A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anaesthesia
- Sponsor
- Melbourne Health
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Recall of procedure
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
In this trial, patients undergoing elective colonoscopy under sedation will be randomised to BIS-guided sedation targeting either "light" (bispectral index [BIS] 70-80) or "deep" (BIS<60) sedation. Sedation will be achieved with a standardised regimen of target-controlled infusion of propofol and fentanyl bolus. The primary end point will be the incidence of procedure recall in each group - this will be assessed at the conclusion of the procedure. The procedural conditions, cardio-respiratory complications and recovery including cognitive function will be assessed during and immediately after the procedure. The incidence of dreaming and patient satisfaction with anaesthesia care will be recorded immediately after the procedure. The study will be complete when the patient leaves the hospital on the day of the procedure.
Detailed Description
Controversy exists about the need for deep sedation or light sedation during elective colonoscopy. Deep sedation ensures amnesia for the procedure and may ensure better operating conditions, but may result in cardiorespiratory side effects and prolonged recovery. Differences exist between countries regarding the prevailing depth of sedation with deeper sedation in general being administered in Australia than the United States. This study aims to explore that controversy.
Investigators
Associate Professor Kate Leslie
Head of Reaseach and Staff anaesthetist, The Royal Melbourne Hospital
Melbourne Health
Eligibility Criteria
Inclusion Criteria
- •Plan for elective outpatient colonoscopy under sedation
- •Able and willing to provide written informed consent for study entry and completion of all study related procedures
- •American Society of Anesthesiologists' (ASA) physical status grade 1-3
Exclusion Criteria
- •Colonoscopy and gastroscopy booked as joint procedures
- •Colonoscopy on emergency patients and/or inpatients
- •Inadequate English comprehension (verbal and written to understand the Participant Information and Consent Form)
- •Intellectual or psychiatric disability that prevents consent to and comprehension of study procedures
- •Significant cognitive impairment that prevents independent conduct of activities of daily living or results in 3rd party procedural consent being obtained
- •ASA physical status grade 4-5
Outcomes
Primary Outcomes
Recall of procedure
Time Frame: 1 day. Day of procedure
Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation
Secondary Outcomes
- Speed and quality of recovery(1 day. Day of procedure only. Measured before discharge from hospital)
- Satisfaction(1 day. Day of procedure only. Measured before discharge from hospital)
- Complications(1 day. Day of procedure only.)
- Dreaming(1 day. Day of procedure.)