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Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00921284
First received: June 13, 2009
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.


Condition Intervention Phase
Anesthesia
 Drug: NaCl 9/00
Drug: dexmedetomidine
 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 Dexmedetomidine

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: 66
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (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 dexmedetomidine group
Experimental: dexmedetomidine
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine
 Drug: dexmedetomidine
1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr

  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,
  • hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
  • history of central nervous system disease,
  • patients receiving a psychotropic treatment or an agonist-antagonist opiate,
  • hypovolemic patients,
  • patients receiving a cardio-vascular treatment,
  • expected bleeding surgical procedure,
  • simultaneous general and loco-regional anesthesia,
  • severe hepatic insufficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921284

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

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00921284     History of Changes
Other Study ID Numbers: 2008/41
Study First Received: June 13, 2009
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on June 17, 2013