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CompletedNCT00547209Drone-N2OUpdated Sep 26, 2016

Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

A Phase 4 interventional study of air and Nitrous oxide in Anesthesia, sponsored by Hopital Foch. Completed at 17 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-26.

Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
672
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Anesthesia
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In context

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • General anaesthesia with controlled ventilation

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
672 participants (actual)

Study arms

  • Active comparator
    1

    ventilation with air and oxygen

    Drug: air

  • Experimental
    2

    ventilation with nitrous oxide and oxygen

    Drug: Nitrous oxide

Interventions

  • Drugair

    60% air combined with 40% oxygen for ventilation

  • DrugNitrous oxide

    60% nitrous oxide combined with 40% oxygen for ventilation

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What researchers measure

Primary outcomes

  1. Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.

    Time frame: during anesthesia

Secondary outcomes

  1. Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.

    Time frame: during anesthesia

  2. Influence of Gender

    Time frame: during anesthesia

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Study locations

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

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. PubMed 16571963 ↗
  • 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. PubMed 16551904 ↗
  • 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. PubMed 24486835 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00547209
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Oct 22, 2007
Start date
Oct 2007
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Sep 26, 2016

Study contacts

Marc Fischler, MD
study chair · Hopital Foch, 92150 Suresnes, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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