Use of Closed-loop Anesthesia in Pediatric Patients | NCT00778505

Studies
Use of Closed-loop Anesthesia in Pediatric Patients

NCT00778505

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Sep 23, 2016Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

Anesthesia

Interventions

Propofol
remifentanil
Propofol
Remifentanil

Countries

France

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty in recruiting

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 22, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

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 22, 2016

Last Update Posted Date

Sep 23, 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

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia

Detailed Description

Not provided

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	closed-loop administration of propofol and remifentanil using bispectral index as the controller	Drug: Propofol Drug: remifentanil
2	Active Comparator	manual administration of propofol and remifentanil according to bispectral index values	Drug: Propofol Drug: Remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propofol	Drug	closed-loop administration using bispectral index as the controller	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of time during which the bispectral index is between 40 and 60		anesthesia

Secondary Outcomes

Measure	Description	Time Frame
propofol and remifentanil doses		anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

class ASA I, II or III
general anesthesia scheduled to last more than one hour
intraoperative hemorrhage planned to be less than 15% of the blood volume

Exclusion Criteria:

Combined general and regional anesthesia,
Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,
History of a neurological or a psychiatric disorder, or central brain lesion,
Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,
Hypersensibility to remifentanil or to a derivate of fentanyl,
Scheduled postoperative ventilation or sedation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Necker Enfants		Paris		75015	France
Hôpital Foch

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D000077208	Remifentanil

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided