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Influence of Esmolol on a Closed-Loop Anesthesia System

This study has been terminated.
(lack of effectiveness)
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: June 2, 2009
Last updated: September 22, 2016
Last verified: September 2016
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil

Condition Intervention Phase
Drug: NaCl 9/00
Drug: Esmolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol

Resource links provided by NLM:

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • administered doses of propofol and of remifentanil during anesthesia [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • delay before recovery [ Time Frame: at the end of anesthesia ] [ Designated as safety issue: No ]
  • hemodynamic abnormalities requiring a treatment [ Time Frame: end of anesthesia ] [ Designated as safety issue: No ]
  • postoperative morphine requirement [ Time Frame: Third post-anesthetic hour ] [ Designated as safety issue: No ]
  • explicit memorisation [ Time Frame: Second postoperative day ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Drug: NaCl 9/00
Same volume as in the esmolol group
Experimental: Esmolol
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol
Drug: Esmolol
1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00922467

Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch Identifier: NCT00922467     History of Changes
Other Study ID Numbers: 2008/47 
Study First Received: June 2, 2009
Last Updated: September 22, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents processed this record on October 28, 2016