Influence of Esmolol on a Closed-Loop Anesthesia System

NCT ID: NCT00922467

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo

Group Type PLACEBO_COMPARATOR

NaCl 9/00

Intervention Type DRUG

Same volume as in the esmolol group

Esmolol

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

Group Type EXPERIMENTAL

Esmolol

Intervention Type DRUG

1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period

Interventions

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NaCl 9/00

Same volume as in the esmolol group

Intervention Type DRUG

Esmolol

1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hôpital Foch

Locations

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Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2008/47

Identifier Type: -

Identifier Source: org_study_id

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