"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy

Not Applicable

Completed

• Conditions: Anaesthesia
• Interventions: Other: Sedation depth

• Registration Number: NCT01457274
• Lead Sponsor: Melbourne Health

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"light" sedation	Sedation depth	In this study the depth of sedation will be guided by the Bispectral Index monitor (BIS monitor). A BIS value of 70-80 will be targeted in the "light" sedation arm.
"deep" sedation	Sedation depth	In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.

Primary Outcome Measures

Name	Time	Method
Recall of procedure	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 Outcome Measures

Name	Time	Method
Speed and quality of recovery	1 day. Day of procedure only. Measured before discharge from hospital	Time from starting sedation until opening eyes in the post anaesthesia care unit, and time until readiness for hospital discharge will be recorded.; Cognitive function at hospital discharge, compared to pre-procedure function, will be assessed by the CogState(TM) test battery.
Satisfaction	1 day. Day of procedure only. Measured before discharge from hospital	Proceduralist and anaesthetist satisfaction with the sedation will be recorded at the end of the procedure.; Patient satisfaction with their anaesthesia care will be assessed at the time they are ready for hospital discharge.
Complications	1 day. Day of procedure only.	The treating anaesthetist will record if any of the following complications occur during the sedation for colonoscopy.; 1. Hypoxia; 2. Airway obstruction; 3. Hypotension; 4. Bradycardia; 5. Agitation
Dreaming	1 day. Day of procedure.	Upon rousing in the post anaesthesia care unit patients will be asked the modified Brice questionnaire ("What is the last thing you remember before you went to sleep?", "What is the first thing you remember when you woke up?", "Did you remember anything in between?", and "Did you have any dreams?").; Dreaming will be assessed by the response to quesion 4.

Trial Locations

Locations (1)

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia