Dexmedetomidine for Morphine Consumption Reduction (DEXDOR) (DEXDOR)

September 13, 2016 updated by: Centre Hospitalier Régional Metz-Thionville

Assessment of the Reducting Effect of Dexmedetomidine on the Morphine Use for Severe Burned Patients

The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.

DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.

Study Overview

Status

Completed

Conditions

Detailed Description

The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.

DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.

This study would manage to develop a protocol using dexmedetomidine to reduce the use of morphine for the sedation-analgesia. It expects a sensitization of physicians about the need to form the nurse crew for the autonomous use of a protocol before performing a new evaluation of sedation-analgesia.

Study Type

Observational

Enrollment (Actual)

32

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
      • Metz Cedex 03, France, 57085
        • CHR Metz-Thionville

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

All

Sampling Method

Probability Sample

Study Population

Severe burned patients cared by the Severe Burned Center between 1st January 2014 and 31 August 2015

Description

Inclusion Criteria:

  • More than 18 years old
  • Hospitalised for severe burning (total burned skin surface higher than 20% and/or smoke inhalation and/or severe comorbidities)
  • Having received a continued dexmedetomidine administration of at least 24 hours for the case group and having received no dexmedetomidine administration for the control group

Exclusion Criteria:

  • Inability to communicate (language barrier, major cognitive disorders)
  • Medical contraindication for dexmedetomidine (hepatocellular insufficiency, hypersensibility, grade II or III atrio-ventricular blocks without device, acute brain vascular pathology).
  • For the control group, pregnancy is a non-inclusion criterion

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global consumption of opioids (including per anesthesia for bandage or surgery) during the patient care period, expressed as intravenous morphine per day equivalent, indexed on the weight (mg.kg-1.j-1).
Time Frame: day 20
mg.kg-1.j-1
day 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance for dexmedetomidine by hemodynamic
Time Frame: day 20
mm Hg
day 20
Efficiency of analgesia
Time Frame: day 20
RASS scale
day 20

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Marie-Reine LOSSER, MD, CHR Metz-Thionville

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

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-03Obs-CHRMT

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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