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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547209

Acronym

Drone-N2O

Enrollment

672

Registered

2007-10-22

Start date

2007-10-31

Completion date

2009-11-30

Last updated

2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGair

60% air combined with 40% oxygen for ventilation

DRUGNitrous oxide

60% nitrous oxide combined with 40% oxygen for ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026