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

NCT ID: NCT01457274

Last Updated: 2015-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

"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.

Group Type: EXPERIMENTAL

Sedation depth

Intervention Type: OTHER

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).

"deep" sedation

In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.

Group Type: ACTIVE_COMPARATOR

Sedation depth

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

BIS monitor; Bispectral index; Aspect medical

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melbourne Health

OTHER

Sponsor Role: lead

Responsible Party

Associate Professor Kate Leslie

Head of Reaseach and Staff anaesthetist, The Royal Melbourne Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan L Allen, BMBS

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Kate Leslie, MBBS

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Royal Melbourne Hospital

Parkville, Victoria, Australia

Countries

Australia

Other Identifiers

2011.066

Identifier Type: -

Identifier Source: org_study_id