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OpenTrials
Completed

NCT Number: NCT01020643

Closed-loop Sedation of Propofol for Patients Undergoing Spinal Anesthesia

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.

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Key information

Conditions

Conscious Sedation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MUHC - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing hip or knee replacement under spinal anesthesia

Exclusion criteria

  • contraindication to spinal anesthesia
  • allergies to any study drug

Treatment and study plan

controlled administration of propofol

Drug

comparison of propofol sedation

Primary outcomes

  1. Controller performance

    Time frame: 1 year

Secondary outcomes

  1. fluid management

    Time frame: end of surgery

    fluid management manual versus guided

Sponsors and collaborators

Lead sponsor

Thomas Hemmerling

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Oct 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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