Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

• Sponsor: Thomas Hemmerling (Other)
• Overall Status: Completed
• CT.gov ID: NCT01020643
• Collaborator: (none)
• Enrollment: 203
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Drug: controlled administration of propofol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 203 participants
• 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
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: controlled sedation using propofol	Drug: controlled administration of propofol; comparison of propofol sedation

Outcome Measures

Primary Outcome Measures

1. Controller performance [1 year]

Secondary Outcome Measures

1. fluid management [end of surgery]

   fluid management manual versus guided

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	MUHC - Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4

Sponsors and Collaborators

• Thomas Hemmerling

Investigators

• Principal Investigator: Thomas Hemmerling, MD, MUHC - MGH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Hemmerling, MSc, MD, DEAA,, McGill University Health Centre/Research Institute of the McGill University Health Centre
• ClinicalTrials.gov Identifier: NCT01020643
• Other Study ID Numbers: 09-168-GEN
• First Posted: Nov 25, 2009
• Last Update Posted: Oct 25, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of Oct 25, 2013