Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

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. Identifier: NCT01020643
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Thomas Hemmerling, McGill University Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Conscious Sedation Drug: controlled administration of propofol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: controlled sedation using propofol Drug: controlled administration of propofol
comparison of propofol sedation

Primary Outcome Measures :
  1. Controller performance [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. fluid management [ Time Frame: end of surgery ]
    fluid management manual versus guided

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01020643

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

Responsible Party: Thomas Hemmerling, MSc, MD, DEAA,, McGill University Health Center Identifier: NCT01020643     History of Changes
Other Study ID Numbers: 09-168-GEN
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General