Influence of Esmolol on a Closed-Loop Anesthesia System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922467
Recruitment Status : Terminated (lack of effectiveness)
First Posted : June 17, 2009
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Hopital Foch

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

Condition or disease Intervention/treatment Phase
Anesthesia Drug: NaCl 9/00 Drug: Esmolol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. administered doses of propofol and of remifentanil during anesthesia [ Time Frame: end of anesthesia ]

Secondary Outcome Measures :
  1. delay before recovery [ Time Frame: at the end of anesthesia ]
  2. hemodynamic abnormalities requiring a treatment [ Time Frame: end of anesthesia ]
  3. postoperative morphine requirement [ Time Frame: Third post-anesthetic hour ]
  4. explicit memorisation [ Time Frame: Second postoperative day ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922467

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

Responsible Party: Hopital Foch Identifier: NCT00922467     History of Changes
Other Study ID Numbers: 2008/47
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

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