Influence of Esmolol on a Closed-Loop Anesthesia System | NCT00922467

Studies
Influence of Esmolol on a Closed-Loop Anesthesia System

NCT00922467

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Sep 23, 2016Estimated

Enrollment

15Actual

Phase

Phase 3

Conditions

Anesthesia

Interventions

NaCl 9/00
Esmolol

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

lack of effectiveness

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 16, 2009

First Posted Date

Jun 17, 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

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

15Actual

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
Esmolol	Experimental	patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol	Drug: Esmolol

Interventions

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

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,
any other history of anaphylactic reaction,
hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
hypersensibility to esmolol or to an excipient,
history of central nervous system disease,
patients receiving a psychotropic treatment or an agonist-antagonist opiate,
hypovolemic patients,
patients receiving a cardio-vascular treatment,
patients with a pacemaker,
expected bleeding more than 20% of the blood volume,
simultaneous general and loco-regional anesthesia,
patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
patients with a heart rate less than 50/min and/or an arterial hypotension,
neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.

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