NCT01019746CompletedPhase 4
Comparison of Closed-oop of Propofol Versus Manual Control Using Bispectral Index (BIS)
McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country40 target enrollmentStarted: August 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Comparison of control administration of propofol with manual administration.
Study Overview
Brief Summary
The purpose of this study is to compare the administration of the standard anesthetic agent (propofol) using this automatic system with the manual administration of propofol by the anesthesiologist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients aged 18 to 90 years
- •surgery lasting more than 30 min
Exclusion Criteria
- •inability to provide informed consent
- •allergies to study drug
Arms & Interventions
control propofol administration
Experimental
Intervention: propofol (Drug)
Outcomes
Primary Outcomes
Comparison of control administration of propofol with manual administration.
Time Frame: 1 year
Secondary Outcomes
- Emergence from anesthesia(1 year)
Investigators
Study Sites (1)
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