Drone-N2O: Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia
Study Details
Study Description
Brief Summary
The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. [during anesthesia]
Secondary Outcome Measures
- Measure: consequences of the use of nitrous oxide on the performance of the automated administration system. [during anesthesia]
- Influence of Gender [during anesthesia]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Erasmes | Brussels | Belgium | ||
| 2 | CHU d'Angers | Angers | France | ||
| 3 | CH Victor Dupouy | Argenteuil | France | 95100 | |
| 4 | CHU de Besançon | Besançon | France | 25030 | |
| 5 | Clinique Saint Augustin | Bordeaux | France | 33000 | |
| 6 | Hôpital Beaujon | Clichy | France | 92110 | |
| 7 | Centre Hospitalier de Dreux | Dreux | France | 28102 | |
| 8 | Hôpital de Bicêtre | Le Kremlin-Bicêtre | France | 94275 | |
| 9 | Institut Paoli-Calmettes | Marseille | France | 13009 | |
| 10 | Centre Hospitalier Territorial Gaston Bourret | Nouméa | France | 98849 | |
| 11 | Hôpital Pitié-Salpêtrière | Paris | France | 75013 | |
| 12 | Hôpital Cochin | Paris | France | 75014 | |
| 13 | Hôpital de Hautepierre | Strasbourg | France | 67200 | |
| 14 | Hôpital Foch | Suresnes | France | 92151 | |
| 15 | Institut Claudius Regaud | Toulouse | France | 31052 | |
| 16 | Hôpital Trousseau | Tours | France | 37044 | |
| 17 | La Charite | Berlin | Germany | D - 10117 |
Sponsors and Collaborators
- Hopital Foch
Investigators
- Study Chair: Marc Fischler, MD, Hopital Foch, 92150 Suresnes, France
Study Documents (Full-Text)
None provided.More Information
Publications
- Karalapillai D, Leslie K, Umranikar A, Bjorksten AR. Nitrous oxide and anesthetic requirement for loss of response to command during propofol anesthesia. Anesth Analg. 2006 Apr;102(4):1088-93.
- Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.
- 2007-08