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

NCT01457274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-04-27

No results posted yet for this study

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.

Conditions

  • Anaesthesia

Interventions

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).

Sponsors & Collaborators

  • Melbourne Health

    lead OTHER

Principal Investigators

  • Megan L Allen, BMBS · Melbourne Health

  • Kate Leslie, MBBS · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457274 on ClinicalTrials.gov