NCT01457274

"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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Melbourne Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-10-21
• Last updated: 2015-04-27

Locations

1 site across 1 country: Australia