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Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020643
First Posted: November 25, 2009
Last Update Posted: October 25, 2013
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.
Information provided by (Responsible Party):
Thomas Hemmerling, McGill University Health Center
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by Thomas Hemmerling, McGill University Health Center:

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

Secondary Outcome Measures:
  • fluid management [ Time Frame: end of surgery ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01020643


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

Responsible Party: Thomas Hemmerling, MSc, MD, DEAA,, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01020643     History of Changes
Other Study ID Numbers: 09-168-GEN
First Submitted: November 23, 2009
First Posted: November 25, 2009
Last Update Posted: October 25, 2013
Last Verified: October 2013

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