NCT01020643CompletedPhase 4
Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Thomas Hemmerling
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- Controller performance
Study Overview
Brief Summary
The purpose of this study is to compare the administration of a standard anesthetic drug (propofol) using an automatic, expert-based system versus a manually controlled system by the anesthesiologist. In addition, the performance of the decision support system will be evaluated.
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 undergoing hip or knee replacement under spinal anesthesia
Exclusion Criteria
- •contraindication to spinal anesthesia
- •allergies to any study drug
Arms & Interventions
controlled sedation using propofol
Experimental
Intervention: controlled administration of propofol (Drug)
Outcomes
Primary Outcomes
Controller performance
Time Frame: 1 year
Secondary Outcomes
- fluid management(end of surgery)
Investigators
Thomas Hemmerling
MSc, MD, DEAA,
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sites (1)
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