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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00547209
First received: October 19, 2007
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Anesthesia
Drug: air
Drug: Nitrous oxide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: consequences of the use of nitrous oxide on the performance of the automated administration system. [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]
  • Influence of Gender [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Enrollment: 672
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ventilation with air and oxygen
Drug: air
60% air combined with 40% oxygen for ventilation
Experimental: 2
ventilation with nitrous oxide and oxygen
Drug: Nitrous oxide
60% nitrous oxide combined with 40% oxygen for ventilation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00547209

Locations
Belgium
Hôpital Erasmes
Brussels, Belgium
France
CHU d'Angers
Angers, France
CH Victor Dupouy
Argenteuil, France, 95100
CHU de Besançon
Besançon, France, 25030
Clinique Saint Augustin
Bordeaux, France, 33000
Hôpital Beaujon
Clichy, France, 92110
Centre Hospitalier de Dreux
Dreux, France, 28102
Hôpital de Bicêtre
Le Kremlin-Bicêtre, France, 94275
Institut Paoli-Calmettes
Marseille, France, 13009
Centre Hospitalier Territorial Gaston Bourret
Nouméa, France, 98849
Hôpital Cochin
Paris, France, 75014
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Hôpital de Hautepierre
Strasbourg, France, 67200
Hôpital Foch
Suresnes, France, 92151
Institut Claudius Regaud
Toulouse, France, 31052
Hôpital Trousseau
Tours, France, 37044
Germany
La Charite
Berlin, Germany, D - 10117
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hopital Foch, 92150 Suresnes, France
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00547209     History of Changes
Other Study ID Numbers: 2007-08
Study First Received: October 19, 2007
Last Updated: January 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 29, 2014