Skip to main content
OpenTrials
Completed

NCT Number: NCT00547209

Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Erasmes, Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air

Drug

60% air combined with 40% oxygen for ventilation

Nitrous Oxide

Drug

60% nitrous oxide combined with 40% oxygen for ventilation

Primary outcomes

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

    Time frame: during anesthesia

Secondary outcomes

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

    Time frame: during anesthesia

  2. Influence of Gender

    Time frame: during anesthesia

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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)

Acronym: Drone-N2O

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2007
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.