Influence of Muscle Relaxation on a Closed-Loop Anesthesia System - Full Text View

Sponsored by:	Hopital Foch
Information provided by:	Hopital Foch
ClinicalTrials.gov Identifier:	NCT00886418

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 III

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Pharmacodynamics Study
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: end of anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	140
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Experimental Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used only to facilitate tracheal intubation; a placebo is infused throughout anesthesia.	Drug: normal saline muscle relaxant administration to facilitate tracheal intubation followed by normal saline throughout anesthesia

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

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:	Hôpital Foch ( Hôpital Foch )
Study ID Numbers:	2008/28
Study First Received:	April 19, 2009
Last Updated:	April 25, 2009
ClinicalTrials.gov Identifier:	NCT00886418 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Muscle Hypotonia
Anesthetics

ClinicalTrials.gov processed this record on May 06, 2009