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

Sponsor

Melbourne Health (Other)

Overall Status

Completed

CT.gov ID

NCT01457274

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anaesthesia	Other: Sedation depth	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Other Names:

BIS monitor

Bispectral index

Aspect medical

Outcome Measures

Primary Outcome Measures

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

Complications [1 day. Day of procedure only.]
The treating anaesthetist will record if any of the following complications occur during the sedation for colonoscopy. Hypoxia Airway obstruction Hypotension Bradycardia Agitation
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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