Influence of Muscle Relaxation on a Closed-loop Anesthesia System (Drone-Curare)
This study is currently recruiting participants.
Verified July 2012 by Hopital Foch
Sponsor:
Hopital Foch
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00886418
First received: April 19, 2009
Last updated: July 9, 2012
Last verified: July 2012
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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 2013 |
| Estimated Primary Completion Date: | January 2013 (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
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: | July 9, 2012 |
| 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 May 21, 2013