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Controlled Propofol Administration

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ClinicalTrials.gov Identifier: NCT01019746
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
HYPNOSIS Drug: propofol Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Closed-oop of Propofol Versus Manual Control Using Bispectral Index (BIS)
Study Start Date : August 2007
Actual Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: control propofol administration Drug: propofol
propofol administration



Primary Outcome Measures :
  1. Comparison of control administration of propofol with manual administration. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Emergence from anesthesia [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019746


Locations
Canada, Quebec
MUHC - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: performance of a novel closed-loop propofol system, MUHC - Montreal General Hospitalization
ClinicalTrials.gov Identifier: NCT01019746     History of Changes
Other Study ID Numbers: GEN-07-002
GEN#07-002
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by McGill University Health Center:
Hypnosis with propofol

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics