Status:

TERMINATED

Influence of Esmolol on a Closed-Loop Anesthesia System

Lead Sponsor:

Hopital Foch

Conditions:

Anesthesia

Eligibility:

MALE

18+ years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • male patients scheduled for a general anesthesia

Exclusion

  • 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.

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2011

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00922467

Start Date

June 1 2009

End Date

December 1 2011

Last Update

September 23 2016

Active Locations (1)

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1

Hôpital Foch

Suresnes, France, 92151