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Influence of Muscle Relaxation on a Closed-loop Anesthesia System (Drone-Curare)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886418
First Posted: April 23, 2009
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  Purpose
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.

Condition Intervention Phase
Anesthesia, General Drug: muscle relaxant Drug: normal saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • propofol dose [ Time Frame: one hour anesthesia ]

Secondary Outcome Measures:
  • remifentanil dose [ Time Frame: one hour anesthesia ]
  • number of automatic modifications of the propofol and remifentanil concentrations [ Time Frame: one hour anesthesia ]
  • number of patients' movements [ Time Frame: one hour anesthesia ]
  • number of hemodynamic abnormalities requiring treatment [ Time Frame: one hour anesthesia ]
  • time to wake up [ Time Frame: end of anesthesia ]
  • intraoperative awareness [ Time Frame: postoperative day 1 or 2 ]
  • performance of the closed-loop system [ Time Frame: one hour anesthesia ]

Enrollment: 140
Study Start Date: December 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia.
Drug: muscle relaxant
muscle relaxant administration throughout anesthesia
Experimental: 2
Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia.
Drug: normal saline
no muscle relaxant throughout anesthesia (normal saline infused as a placebo)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for a surgical procedure which not require a myorelaxation

Exclusion Criteria:

  • age less than 18 years,
  • ASA III and above,
  • pregnant woman
  • combined general and regional anesthesia,
  • history of prolonged myorelaxation due to a decrease in cholinesterase,
  • patient with a known lack in cholinesterase,
  • history of cerebral or psychiatric central,
  • allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
  • known hypersensitivity to remifentanil or to an other derivative of fentanyl,
  • presence of a pacemaker,
  • psychotropic or agonist-antagonist morphine treatment,
  • planned post-operative sedation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886418


Locations
France
CHU Besançon
Besançon, France, 25000
Institut Paoli-Calmette
Marseille, France, 13273
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00886418     History of Changes
Other Study ID Numbers: 2008/28
First Submitted: April 19, 2009
First Posted: April 23, 2009
Last Update Posted: September 23, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs