Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Hemmerling, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01020643
First received: November 23, 2009
Last updated: October 24, 2013
Last verified: October 2013
  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: 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

  Eligibility

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

No publications provided

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
Study First Received: November 23, 2009
Last Updated: October 24, 2013
Health Authority: Canada: Ethics Review Committee

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 April 16, 2014