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
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: 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, 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 04, 2016