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NCT01020643 Clinical Trial

Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

Conscious Sedation Clinical Trial

Official title:
Comparison of Closed-loop Control System of Propofol Versus Manual Control Using Bispectral Index for Controlled Sedation - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01020643
Other study ID # 09-168-GEN
Secondary ID
Status Completed
Phase Phase 4
First received November 23, 2009
Last updated October 24, 2013
Start date November 2009
Est. completion date August 2011

Study information
Verified date October 2013
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria:

- contraindication to spinal anesthesia

- allergies to any study drug

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• controlled administration of propofol
comparison of propofol sedation

Locations
Country Name City State
Canada MUHC - Montreal General Hospital Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Thomas Hemmerling

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Controller performance 1 year No
Secondary fluid management fluid management manual versus guided end of surgery No
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