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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00886418
First received: April 19, 2009
Last updated: September 21, 2014
Last verified: September 2014

April 19, 2009
September 21, 2014
December 2009
January 2015   (final data collection date for primary outcome measure)
propofol dose [ Time Frame: one hour anesthesia ] [ Designated as safety issue: No ]
propofol dose [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00886418 on ClinicalTrials.gov Archive Site
  • 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 ]
  • remifentanil dose [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • number of automatic modifications of the propofol and remifentanil concentrations [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • number of patients' movements [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • number of hemodynamic abnormalities requiring treatment [ Time Frame: end of 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: end of anesthesia ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Influence of Muscle Relaxation on a Closed-loop Anesthesia System
Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Anesthesia, General
  • Drug: muscle relaxant
    muscle relaxant administration throughout anesthesia
  • Drug: normal saline
    no muscle relaxant throughout anesthesia (normal saline infused as a placebo)
  • 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.
    Intervention: Drug: muscle relaxant
  • 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.
    Intervention: Drug: normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
January 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org
France
 
NCT00886418
2008/28
No
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP