Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia
NCT ID: NCT00547209
Last Updated: 2016-09-26
Study Results
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Basic Information
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COMPLETED
PHASE4
672 participants
INTERVENTIONAL
2007-10-31
2009-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
ventilation with air and oxygen
air
60% air combined with 40% oxygen for ventilation
2
ventilation with nitrous oxide and oxygen
Nitrous oxide
60% nitrous oxide combined with 40% oxygen for ventilation
Interventions
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air
60% air combined with 40% oxygen for ventilation
Nitrous oxide
60% nitrous oxide combined with 40% oxygen for ventilation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Marc Fischler, MD
Role: STUDY_CHAIR
Hopital Foch, 92150 Suresnes, France
Locations
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Hôpital Erasmes
Brussels, , Belgium
CHU d'Angers
Angers, , France
CH Victor Dupouy
Argenteuil, , France
CHU de Besançon
Besançon, , France
Clinique Saint Augustin
Bordeaux, , France
Hôpital Beaujon
Clichy, , France
Centre Hospitalier de Dreux
Dreux, , France
Hôpital de Bicêtre
Le Kremlin-Bicêtre, , France
Institut Paoli-Calmettes
Marseille, , France
Centre Hospitalier Territorial Gaston Bourret
Nouméa, , France
Hôpital Pitié-Salpêtrière
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital de Hautepierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Institut Claudius Regaud
Toulouse, , France
Hôpital Trousseau
Tours, , France
La Charite
Berlin, , Germany
Countries
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References
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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. doi: 10.1097/00000542-200604000-00012.
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. doi: 10.1213/01.ane.0000198672.05639.0a.
Liu N, Le Guen M, Boichut N, Genty A, Herail T, Schmartz D, Khefif G, Landais A, Bussac JJ, Charmeau A, Baars J, Rehberg B, Tricoche S, Chazot T, Sessler DI, Fischler M. Nitrous oxide does not produce a clinically important sparing effect during closed-loop delivered propofol-remifentanil anaesthesia guided by the bispectral index: a randomized multicentre study. Br J Anaesth. 2014 May;112(5):842-51. doi: 10.1093/bja/aet479. Epub 2014 Jan 31.
Other Identifiers
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2007-08
Identifier Type: -
Identifier Source: org_study_id
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