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Recruiting Phase 3 NCT07166991

Anesthesia sTrategy foR Organ Procurement In braiN dEath

Trial Parameters

Condition Brain-dead Organ Donors
Sponsor University Hospital, Grenoble
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 270
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-02-17
Completion 2028-09-01
Interventions
Volatile anestheticOpioid AnesthesiaIntraoperative brain-dead donor management

Brief Summary

The optimal anesthetic strategy during organ procurement in brain-dead donors remains unknown. The administration of anesthetic drugs in this setting aims to preserve hemodynamic stability in the face of reflex responses mediated by preserved spinal activity. Volatile anesthetics may blunt these reflexes, but their potential benefits in this context have never been investigated. This randomized trial evaluates the effects of volatile anesthesia (sevoflurane), opioid administration (sufentanil), or no anesthetic drugs on intraoperative hemodynamic stability during organ procurement in brain-dead donors. The primary outcome is the proportion of operative time within a predefined arterial blood pressure range.

Eligibility Criteria

Inclusion Criteria: * Eligible adult brain-dead donor hospitalized in intensive care unit in one of the participating center: * Confirmed diagnosis of brain death according to French public health code. * Ongoing organ donation procedure managed by the local organ procurement coordination team with confirmation of the potential procurement of at least one intra-abdominal or intra-thoracic organ. * Transfer to the operating room for the organ procurement procedure scheduled for the next 6 hours and anesthesia team alerted. * Information of the patient's next of kin by the investigator and absence of opposition to research confirmed by the testimony of the next of kin according to French public health code. Exclusion Criteria: * Age \< 18 years. * DCD (donation after circulatory death) donors. * Ongoing extracorporeal circulation at the time of death. * Hemodynamic instability at the screening visit defined by a noradrenalin dose \> 1 µg/kg/min. * Contraindication to the implementation o

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