Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia (Drone-N2O)
This study has been completed.
Sponsor:
Hopital Foch
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
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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:
MedlinePlus related topics:
Oxygen Therapy
Drug Information available for:
Nitrous oxide
U.S. FDA Resources
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
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 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:
Liu N, Hamada S, Chazot T, Landais A, Fischler M. Propofol and Remifentanil Guided Solely by the Bispectral Index: Closed-Loop Versus Manual Control. Anesthesiology ASA A854, 2006.
| 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:
|
Anesthetics Nitrous Oxide 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 Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on June 18, 2013