Influence of Dexmedetomidine 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: NCT00921284
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Hopital Foch

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 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 Dexmedetomidine
Study Start Date : June 2009
Primary Completion Date : July 2011
Study Completion Date : July 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 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

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,
  • 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.

Information from the National Library of Medicine

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): NCT00921284

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

Responsible Party: Hopital Foch Identifier: NCT00921284     History of Changes
Other Study ID Numbers: 2008/41
First Posted: June 16, 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, Non-Narcotic
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