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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547209
First Posted: October 22, 2007
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hopital Foch
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pitié-Salpêtrière
Paris, France, 75013
Hôpital Cochin
Paris, France, 75014
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:
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
First Submitted: October 19, 2007
First Posted: October 22, 2007
Last Update Posted: September 26, 2016
Last Verified: September 2016

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