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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00886418
First received: April 19, 2009
Last updated: September 22, 2016
Last verified: September 2016
  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 ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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 
Study First Received: April 19, 2009
Last Updated: September 22, 2016
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

ClinicalTrials.gov processed this record on September 28, 2016