Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

Phase 4

Completed

• Conditions: Conscious Sedation
• Interventions: Drug: controlled administration of propofol

• Registration Number: NCT01020643
• Lead Sponsor: Thomas Hemmerling

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• patients undergoing hip or knee replacement under spinal anesthesia

Exclusion Criteria

• contraindication to spinal anesthesia
• allergies to any study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled sedation using propofol	controlled administration of propofol	-

Primary Outcome Measures

Name	Time	Method
Controller performance	1 year

Secondary Outcome Measures

Name	Time	Method
fluid management	end of surgery	fluid management manual versus guided

Trial Locations

Locations (1)

MUHC - Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada