NCT00547209

Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 672 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	air	60% air combined with 40% oxygen for ventilation
DRUG	Nitrous oxide	60% nitrous oxide combined with 40% oxygen for ventilation

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-10-22
• Last updated: 2016-09-26

Locations

17 sites across 3 countries: Belgium, France, Germany