Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

September 22, 2016 updated by: Hopital Foch

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92151
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
administered doses of propofol and of remifentanil during anesthesia
Time Frame: end of anesthesia
end of anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
delay before recovery
Time Frame: at the end of anesthesia
at the end of anesthesia
hemodynamic abnormalities requiring a treatment
Time Frame: end of anesthesia
end of anesthesia
postoperative morphine requirement
Time Frame: Third post-anesthetic hour
Third post-anesthetic hour
explicit memorisation
Time Frame: Second postoperative day
Second postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 13, 2009

First Submitted That Met QC Criteria

June 13, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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