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Completed

NCT Number: NCT00921284

Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

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

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Foch

Suresnes, 92151, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NaCl 9/00

Drug

Same volume as in the dexmedetomidine group

Dexmedetomidine

Drug

1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr

Primary outcomes

  1. administered doses of propofol and of remifentanil during anesthesia

    Time frame: end of anesthesia

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2009
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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