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Completed

NCT Number: NCT02904460

Dexmedetomidine for Morphine Consumption Reduction (DEXDOR)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Tolerance for dexmedetomidine by hemodynamic

    Time frame: day 20

    mm Hg

  2. Efficiency of analgesia

    Time frame: day 20

    RASS scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: DEXDOR

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2016
Registry last updated
Sep 19, 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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