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Controlled Propofol Administration

This study has been completed.
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01019746
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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: 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:

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019746

Locations
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 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
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:
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 19, 2013