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Controlled Propofol Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01019746
First Posted: November 25, 2009
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McGill University Health Center
  Purpose
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 Intervention Phase
HYPNOSIS Drug: propofol Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

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

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

Estimated Enrollment: 40
Study Start Date: August 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: control propofol administration Drug: propofol
propofol administration

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: November 23, 2009
First Posted: November 25, 2009
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