Dexmedetomidine for Morphine Consumption Reduction (DEXDOR)

NCT02904460 | Completed

• 1 other identifier: 2015-03Obs-CHRMT
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burning

Outcome Measures

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).

  mg.kg-1.j-1

  day 20

Secondary Outcomes (2)

• Tolerance for dexmedetomidine by hemodynamic

  day 20

• Efficiency of analgesia

  day 20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Paresthesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie-Reine LOSSER, MD

  CHR Metz-Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 19, 2016

Record last verified: 2016-08

Locations

FR (1)