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Clinical Trials/NCT01020643
NCT01020643
Completed
Phase 4

Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study

Thomas Hemmerling1 site in 1 country203 target enrollmentNovember 2009
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ConditionsConscious Sedation
Interventionscontrolled administration of propofol
Drugscontrolled administration of propofol

Overview

Phase
Phase 4
Intervention
controlled administration of propofol
Conditions
Conscious Sedation
Sponsor
Thomas Hemmerling
Enrollment
203
Locations
1
Primary Endpoint
Controller performance
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
August 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Thomas Hemmerling

MSc, MD, DEAA,

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

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

Intervention: controlled administration of propofol

Outcomes

Primary Outcomes

Controller performance

Time Frame: 1 year

Secondary Outcomes

  • fluid management(end of surgery)

Study Sites (1)

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