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

A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery

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.

Study Overview

• Status: Completed
• Conditions: Anaesthesia
• Intervention / Treatment: Other: Sedation depth

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "light" sedation; 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.	Other: Sedation depth; The intervention is the depth of sedation targeted in this study. Patients enrolled in this study will be sedated with the same medications (fentanyl bolus and propofol target controlled infusion), and at the same starting doses, in each study arm. However, the depth of sedation targeted will differ between the arms, and this depth will be guided by the BIS monitor. It is expected that those patients randomised to "deep" sedation will require a higher dose of sedative medication to achieve their target BIS value (<60) than those in the "light" sedation group (BIS 70-80).; Other Names: BIS monitor; Bispectral index; Aspect medical
Active Comparator: "deep" sedation; In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.	Other: Sedation depth; The intervention is the depth of sedation targeted in this study. Patients enrolled in this study will be sedated with the same medications (fentanyl bolus and propofol target controlled infusion), and at the same starting doses, in each study arm. However, the depth of sedation targeted will differ between the arms, and this depth will be guided by the BIS monitor. It is expected that those patients randomised to "deep" sedation will require a higher dose of sedative medication to achieve their target BIS value (<60) than those in the "light" sedation group (BIS 70-80).; Other Names: BIS monitor; Bispectral index; Aspect medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of procedure	Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation	1 day. Day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	The treating anaesthetist will record if any of the following complications occur during the sedation for colonoscopy.; Hypoxia; Airway obstruction; Hypotension; Bradycardia; Agitation	1 day. Day of procedure only.
Speed and quality of recovery	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.	1 day. Day of procedure only. Measured before discharge from hospital
Satisfaction	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.	1 day. Day of procedure only. Measured before discharge from hospital
Dreaming	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.	1 day. Day of procedure.

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: Megan L Allen, BMBS, Melbourne Health; Principal Investigator: Kate Leslie, MBBS, Melbourne Health

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Estimate): April 27, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Colonoscopy; Propofol; Procedural sedation; AMBULATORY CARE; AWARENESS AND RECALL; Patient Safety and Satisfaction; Elective outpatient colonoscopy
• Other Study ID Numbers: 2011.066