Controlled Propofol Administration

This study has been completed.
Information provided by:
McGill University Health Center Identifier:
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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
Drug: propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emergence from anesthesia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01019746

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

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: performance of a novel closed-loop propofol system, MUHC - Montreal General Hospitalization Identifier: NCT01019746     History of Changes
Other Study ID Numbers: GEN-07-002  GEN#07-002 
Study First Received: November 23, 2009
Last Updated: November 23, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Hypnosis with propofol

Additional relevant MeSH terms:
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 11, 2016