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

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: April 19, 2009
Last updated: September 22, 2016
Last verified: September 2016
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)


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

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
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Please refer to this study by its identifier: NCT00886418

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

Responsible Party: Hopital Foch Identifier: NCT00886418     History of Changes
Other Study ID Numbers: 2008/28
Study First Received: April 19, 2009
Last Updated: September 22, 2016

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 21, 2017