Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

This study has been completed.
Information provided by (Responsible Party):
Thomas Hemmerling, McGill University Health Center Identifier:
First received: November 23, 2009
Last updated: October 24, 2013
Last verified: October 2013

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.

Condition Intervention Phase
Conscious Sedation
Drug: controlled administration of 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-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Controller performance [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fluid management [ Time Frame: end of surgery ] [ Designated as safety issue: No ]
    fluid management manual versus guided

Enrollment: 203
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: controlled sedation using propofol Drug: controlled administration of propofol
comparison of propofol sedation


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria:

  • contraindication to spinal anesthesia
  • allergies to any study drug
  Contacts and Locations
Please refer to this study by its identifier: NCT01020643

Canada, Quebec
MUHC - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Thomas Hemmerling
Principal Investigator: Thomas Hemmerling, MD MUHC - MGH
  More Information

No publications provided

Responsible Party: Thomas Hemmerling, MSc, MD, DEAA,, McGill University Health Center Identifier: NCT01020643     History of Changes
Other Study ID Numbers: 09-168-GEN
Study First Received: November 23, 2009
Last Updated: October 24, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives processed this record on April 16, 2014