Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by McGill University Health Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
McGill University Health Center
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01020643
First received: November 23, 2009
Last updated: June 7, 2011
Last verified: November 2009
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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
| Estimated Enrollment: | 230 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | April 2012 (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
Contacts
| Contact: Thomas M Hemmerling, MD | 514'934'1934 ext 43677 | thomas.hemmerling@mcgill.ca |
Locations
| Canada, Quebec | |
| MUHC - Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Contact: Thomas M Hemmerling, MD 514-934-1934 ext 43677 thomas.hemmerling@mcgill.ca | |
Sponsors and Collaborators
McGill University Health Center
Investigators
| Principal Investigator: | Thomas Hemmerling, MD | MUHC - MGH |
More Information
No publications provided
| Responsible Party: | Prof Thomas M Hemmerling, MUHC - MGH |
| ClinicalTrials.gov Identifier: | NCT01020643 History of Changes |
| Other Study ID Numbers: | 09-168-GEN |
| Study First Received: | November 23, 2009 |
| Last Updated: | June 7, 2011 |
| 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 May 23, 2013