Effect of Nitrous Oxide on Intravenous Closed-Loop Anesthesia - Full Text View

Sponsored by:	Hopital Foch
Information provided by:	Hopital Foch
ClinicalTrials.gov Identifier:	NCT00547209

Purpose

The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.

Condition	Intervention	Phase
Anesthesia	Drug: air Drug: Nitrous oxide	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Nitrous oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Anesthésie Totale Intraveineuse en " Boucle d'Asservissement " guidée Par l'Index Bispectral : Effet de l'Adjonction de Protoxyde d'Azote (Effect of Nitrous Oxide on Intravenous Closed-Loop Anesthesia)

Further study details as provided by Hopital Foch:

Primary Outcome Measures:

Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure: consequences of the use of nitrous oxide on the performance of the automated administration system. [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]
Influence of Gender [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment:	560
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ventilation with air and oxygen	Drug: air 60% air combined with 40% oxygen for ventilation
2: Experimental ventilation with nitrous oxide and oxygen	Drug: Nitrous oxide 60% nitrous oxide combined with 40% oxygen for ventilation

Detailed Description:

Nitrous oxide is a widely used anesthetic agent. The mechanism of its central action is not completely understood and its importance is questioned.

Total intravenous anesthesia can be driven by a computer using bispectral index as a controller. Such a system matches anesthetic agent requirements to the needs of each individuum and thus allows an unbiased evaluation of the influence of nitrous oxide. Two groups of patients are compared: one ventilated with a oxygen-air mixture and one with oxygen-nitrous oxide mixture. Anesthesia is provided by a "dual-loop" which adapts propofol and remifentanil target concentrations to maintain a bispectral index between 40 and 60 in both groups.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

General anaesthesia with controlled ventilation

Exclusion Criteria:

Age lower than 18 years
Pregnant woman
Allergy to the propofol or to a muscle myorelaxant
Patients receiving a psychotropic treatment
Presence of a central neurological disorder or a lesion cerebral
Patients having an anomaly of blood cells count preoperative biological assessment
Patients having had an anaesthesia in the previous month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547209

Contacts

Contact: Marc Fischler, MD

33145575606

m.fischler@hopitalfoch.org

Locations

Belgium
Hôpital Erasmes	Recruiting
Brussels, Belgium
Contact: Denis Schmartz + 32 2 5553919 denis.schmartz@ulb.ac.be
Principal Investigator: Denis Schmartz, MD
France
Hôpital Foch	Recruiting
Suresnes, France, 92151
Contact: Ngai Liu, MD 0033145575606 n.liu@hopital-foch.org
Principal Investigator: Ngai Liu, MD
CHU d'Angers	Recruiting
Angers, France
Contact: Laurent Beydon, MD lbeydon.angers@invivo.edu
Principal Investigator: Laurent Beydon, MD
CH Victor Dupouy	Recruiting
Argenteuil, France, 95100
Contact: Alain Landais, MD alain.landais@ch-argenteuil.fr
Principal Investigator: Alain Landais, MD
Clinique Saint Augustin	Recruiting
Bordeaux, France, 33000
Contact: Antoine Genty, MD antoinegenty@aol.com
Principal Investigator: Antoine gentil, MD
CHU de Besançon	Recruiting
Besançon, France, 25030
Contact: Emmanuel Samain, MD esamain@chu-besancon.fr
Principal Investigator: Emmanuel Samain, MD
Hôpital de Bicêtre	Recruiting
Le Kremlin-Bicêtre, France, 94275
Contact: Jacques Duranteau, MD jacquesduranteau@bct.aphp.fr
Principal Investigator: Jacques Duranteau, MD
Hôpital Beaujon	Recruiting
Clichy, France, 92110
Contact: Jean Mantz, MD jean.mantz@bjn.aphp.fr
Principal Investigator: Jean Mantz, MD
Hôpital Cochin	Recruiting
Paris, France, 75014
Contact: Yves Ozier, MD Yves.ozier@cch.aphp.fr
Principal Investigator: Yves Ozier, MD
Hôpital Pitié-Salpêtrière	Recruiting
Paris, France, 75013
Contact: Morgan LeGuen, MD morgan.le-guen@wanadoo.fr
Principal Investigator: Morgan LeGuen, MD
Institut Paoli-Calmettes	Recruiting
Marseille, France, 13009
Contact: Jean-Louis Blache, MD blachejl@marseille.fnclcc.fr
Principal Investigator: Jean-Louis Blache, MD
Centre Hospitalier Territorial Gaston Bourret	Recruiting
Nouméa, France, 98849
Contact: Olivier Mullerstedt, MD o.mullerstedt@cht.nc
Principal Investigator: Olivier Mullerstedt, MD
Hôpital de Hautepierre	Recruiting
Strasbourg, France, 67200
Contact: Pierre Diemunsch, MD pierre.diemunsch@chru-strasbourg.fr
Principal Investigator: Pierre Diemunsch, MD
Hôpital Trousseau	Recruiting
Tours, France, 37044
Contact: Jacques Fusciardi, MD fusciardi@med.univ-tours.fr
Principal Investigator: Jacques Fusciardi, MD
Centre Hospitalier de Dreux	Recruiting
Dreux, France, 28102
Contact: T. Herail, MD therail@free.fr
Principal Investigator: T. Herail, MD
Institut Claudius Regaud	Recruiting
Toulouse, France, 31052
Contact: Pierre Rouge, MD Rouge.Pierre@claudiusregaud.fr
Principal Investigator: Pierre Rouge, MD
Germany
La Charite	Not yet recruiting
Berlin, Germany, D - 10117
Contact: Benno Rehberg, MD +49-(0)30 450 631070 benno.rehberg@charite.de
Principal Investigator: Bruno Rehberg, MD

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair:

Marc Fischler, MD

Hopital Foch, 92150 Suresnes, France

More Information

Publications:

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

Liu N, Hamada S, Chazot T, Landais A, Fischler M. Propofol and Remifentanil Guided Solely by the Bispectral Index: Closed-Loop Versus Manual Control. Anesthesiology ASA A854, 2006.

Karalapillai D, Leslie K, Umranikar A, Bjorksten AR. Nitrous oxide and anesthetic requirement for loss of response to command during propofol anesthesia. Anesth Analg. 2006 Apr;102(4):1088-93.

Responsible Party:	Hopital Foch ( Professor Fischler )
Study ID Numbers:	2007-08
Study First Received:	October 19, 2007
Last Updated:	April 5, 2009
ClinicalTrials.gov Identifier:	NCT00547209 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Nitrous Oxide

Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Analgesics

Additional relevant MeSH terms:

Nitrous Oxide
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Anesthetics, Inhalation
Analgesics, Non-Narcotic

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009