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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00886418
First received: April 19, 2009
Last updated: January 7, 2014
Last verified: January 2014
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • propofol dose [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • remifentanil dose [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]
  • number of automatic modifications of the propofol and remifentanil concentrations [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]
  • number of patients' movements [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]
  • number of hemodynamic abnormalities requiring treatment [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]
  • time to wake up [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • intraoperative awareness [ Time Frame: postoperative day 1 or 2 ] [ Designated as safety issue: No ]
  • performance of the closed-loop system [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886418

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
CHU Besançon Recruiting
Besançon, France, 25000
Contact: Nathalie Boichut, MD    381668166 ext 00331    nboichut@chu-besancon.fr   
Institut Paoli-Calmette Recruiting
Marseille, France, 13273
Contact: Daniel Francon, MD    491223333 ext 00331    FRANCOND@marseille.fnclcc.fr   
Hôpital Foch Recruiting
Suresnes, France, 92151
Contact: Thierry Chazot, MD    146252767 ext 00331    t.chazot@hopital-foch.org   
Principal Investigator: Thierry Chazot, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00886418     History of Changes
Other Study ID Numbers: 2008/28
Study First Received: April 19, 2009
Last Updated: January 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014