Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

Hopital Foch672 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

672

Conditions

Anesthesia

Interventions

airDRUG

60% air combined with 40% oxygen for ventilation

Nitrous oxideDRUG

60% nitrous oxide combined with 40% oxygen for ventilation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Hôpital Erasmes

Brussels, Belgium

CHU d'Angers

Angers, France

CH Victor Dupouy

Argenteuil, France

Outcomes

Primary Outcomes

Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.

Time frame: during anesthesia

Secondary Outcomes

Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.

Time frame: during anesthesia

Influence of Gender

Time frame: during anesthesia

Data from ClinicalTrials.gov

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