Status:
COMPLETED
"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy
Lead Sponsor:
Melbourne Health
Conditions:
Anaesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
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....
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01457274
Start Date
September 1 2011
End Date
December 1 2014
Last Update
April 27 2015
Active Locations (1)
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1
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050