Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

Anesthesia Clinical Trial

— Drone-N2O  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547209
• Other study ID #: 2007-08
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2007
• Last updated: September 23, 2016
• Start date: October 2007
• Est. completion date: November 2009

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• air
60% air combined with 40% oxygen for ventilation
• Nitrous oxide
60% nitrous oxide combined with 40% oxygen for ventilation

Locations

Country	Name	City	State
Belgium	Hôpital Erasmes	Brussels
France	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 Cochin	Paris
France	Hôpital Pitié-Salpêtrière	Paris
France	Hôpital de Hautepierre	Strasbourg
France	Hôpital Foch	Suresnes
France	Institut Claudius Regaud	Toulouse
France	Hôpital Trousseau	Tours
Germany	La Charite	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

References & Publications (2)

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. — View Citation

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.		during anesthesia	No
Secondary	Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.		during anesthesia	No
Secondary	Influence of Gender		during anesthesia	No