Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: air; Drug: Nitrous oxide

• Registration Number: NCT00547209
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-19
• Study First Posted: 2007-10-22
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 672

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	air	ventilation with air and oxygen
2	Nitrous oxide	ventilation with nitrous oxide and oxygen

Primary Outcome Measures

Name	Time	Method
Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.	during anesthesia

Secondary Outcome Measures

Name	Time	Method
Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.	during anesthesia
Influence of Gender	during anesthesia

Trial Locations

Locations (17)

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Erasmes; 🇧🇪 Brussels, Belgium

Hôpital Cochin; 🇫🇷 Paris, 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

Centre Hospitalier Territorial Gaston Bourret; 🇫🇷 Nouméa, France

Hôpital de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hôpital Trousseau; 🇫🇷 Tours, France

La Charite; 🇩🇪 Berlin, Germany