Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia (Drone-N2O)

Hopital Foch

Status and phase

Completed

Phase 4

Conditions

Anesthesia

Treatments

Drug: Nitrous oxide

Drug: air

Study type

Interventional

Funder types

Other

Identifiers

NCT00547209

2007-08

Details and patient eligibility

About

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

Full 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.

Enrollment

672 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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