Clinical trial NCT00547209: Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2007-10-22
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.
timeFrame: during anesthesia
Secondary outcomes:
measure: Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.
timeFrame: during anesthesia
measure: Influence of Gender
timeFrame: during anesthesia
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasmes
city: Angers
country: France
facility: CHU d'Angers
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Clichy
country: France
facility: Hôpital Beaujon
city: Dreux
country: France
facility: Centre Hospitalier de Dreux
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital de Bicêtre
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nouméa
country: France
facility: Centre Hospitalier Territorial Gaston Bourret
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: Hôpital Trousseau
city: Berlin
country: Germany
facility: La Charite
Study officials:
affiliation: Hopital Foch, 92150 Suresnes, France
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.