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

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)

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: air; Drug: Nitrous oxide

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 Type: Interventional
• Enrollment (Actual): 672
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.	during anesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.	during anesthesia
Influence of Gender	during anesthesia

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Study Chair: Marc Fischler, MD, Hopital Foch, 92150 Suresnes, France

Publications and helpful links

General Publications

• Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe 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. doi: 10.1097/00000542-200604000-00012.
• 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. doi: 10.1213/01.ane.0000198672.05639.0a.
• Liu N, Le Guen M, Boichut N, Genty A, Herail T, Schmartz D, Khefif G, Landais A, Bussac JJ, Charmeau A, Baars J, Rehberg B, Tricoche S, Chazot T, Sessler DI, Fischler M. Nitrous oxide does not produce a clinically important sparing effect during closed-loop delivered propofol-remifentanil anaesthesia guided by the bispectral index: a randomized multicentre study. Br J Anaesth. 2014 May;112(5):842-51. doi: 10.1093/bja/aet479. Epub 2014 Jan 31.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: October 19, 2007
• First Submitted That Met QC Criteria: October 19, 2007
• First Posted (Estimate): October 22, 2007

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: 2007-08 (Other Identifier: Centre Oscar Lambret)