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Influence of Esmolol on a Closed-Loop Anesthesia System

This study has been terminated.
(lack of effectiveness)
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00922467
First received: June 2, 2009
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Anesthesia
 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922467

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

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00922467     History of Changes
Other Study ID Numbers: 2008/47
Study First Received: June 2, 2009
Last Updated: January 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013