Influence of Dexmedetomidine on a Closed-Loop Anesthesia... | NCT00921284

Studies
Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

NCT00921284

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Sep 23, 2016Estimated

Enrollment

66Actual

Phase

Phase 3

Conditions

Anesthesia

Interventions

NaCl 9/00
dexmedetomidine

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jun 13, 2009

First Submission Date that Met QC Criteria

Jun 13, 2009

First Posted Date

Jun 16, 2009Estimated

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

The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo	Drug: NaCl 9/00
dexmedetomidine	Experimental	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine	Drug: dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NaCl 9/00	Drug	Same volume as in the dexmedetomidine group	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
administered doses of propofol and of remifentanil during anesthesia		end of anesthesia

Secondary Outcomes

Measure	Description	Time Frame
delay before recovery		at the end of anesthesia
hemodynamic abnormalities requiring a treatment		end of anesthesia
postoperative morphine requirement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male patients scheduled for a general anesthesia

Exclusion Criteria:

age lower than 18 years
allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient,
hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
history of central nervous system disease,
patients receiving a psychotropic treatment or an agonist-antagonist opiate,
hypovolemic patients,
patients receiving a cardio-vascular treatment,
expected bleeding surgical procedure,
simultaneous general and loco-regional anesthesia,
severe hepatic insufficiency.

Accepts Healthy Volunteers

Sex

Male

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	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Foch		Suresnes		92151	France

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided