NCT00547209

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
672

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

October 19, 2007

Last Update Submit

September 23, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

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

    during anesthesia

Secondary Outcomes (2)

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

    during anesthesia

  • Influence of Gender

    during anesthesia

Study Arms (2)

1

ACTIVE COMPARATOR

ventilation with air and oxygen

Drug: air

2

EXPERIMENTAL

ventilation with nitrous oxide and oxygen

Drug: Nitrous oxide

Interventions

airDRUG

60% air combined with 40% oxygen for ventilation

1
Nitrous oxideDRUG

60% nitrous oxide combined with 40% oxygen for ventilation

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General anaesthesia with controlled ventilation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hôpital Erasmes

Brussels, Belgium

Location

CHU d'Angers

Angers, France

Location

CH Victor Dupouy

Argenteuil, 95100, France

Location

CHU de Besançon

Besançon, 25030, France

Location

Clinique Saint Augustin

Bordeaux, 33000, France

Location

Hôpital Beaujon

Clichy, 92110, France

Location

Centre Hospitalier de Dreux

Dreux, 28102, France

Location

Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Centre Hospitalier Territorial Gaston Bourret

Nouméa, 98849, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital de Hautepierre

Strasbourg, 67200, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Hôpital Trousseau

Tours, 37044, France

Location

La Charite

Berlin, D - 10117, Germany

Location

Related Publications (3)

  • 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.

    PMID: 16571963BACKGROUND

  • 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.

    PMID: 16551904BACKGROUND

  • 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.

    PMID: 24486835DERIVED

MeSH Terms

Interventions

AirNitrous Oxide

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthNitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Marc Fischler, MD

    Hopital Foch, 92150 Suresnes, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 22, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 26, 2016

Record last verified: 2016-09

Locations

BE(1)DE(1)FR(15)