Effect of Nitrous Oxide on Intravenous Closed-loop Anesth... | NCT00547209

Studies
Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia

NCT00547209

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Sep 26, 2016Estimated

Enrollment

672Actual

Phase

Phase 4

Conditions

Anesthesia

Interventions

air
Nitrous oxide

Countries

Belgium
France
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Oct 19, 2007

First Submission Date that Met QC Criteria

Oct 19, 2007

First Posted Date

Oct 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2016

Last Update Posted Date

Sep 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

672Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	ventilation with air and oxygen	Drug: air
2	Experimental	ventilation with nitrous oxide and oxygen	Drug: Nitrous oxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
air	Drug	60% air combined with 40% oxygen for ventilation	1
Nitrous oxide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Fischler, MD	Hopital Foch, 92150 Suresnes, France	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Erasmes		Brussels			Belgium
CHU d'Angers

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16571963	Background	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.
16551904

ID	Term
D000388	Air
D009609	Nitrous Oxide

ID	Term
D001272	Atmosphere
D004777	Environment
D055669	Ecological and Environmental Phenomena
D001686	Biological Phenomena