Anesthesia sTrategy foR Organ Procurement In braiN dEath

NCT07166991 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Grenoble

Phase

Phase 3

Started

2026-02-17

Last updated

2026-02-23

Condition(s) studied

Brain-dead Organ Donors

Investigational drug(s) / intervention(s)

Volatile anestheticOpioid AnesthesiaIntraoperative brain-dead donor management

Volatile anesthetic: In the volatile anesthetic group, sevoflurane will be administrated during the organ procurement procedure. Administration will be initiated progressively after moving in the operating room and will be pursued until aortic clamping (targeted end-expiratory concentration suggested between 1 and 2%). No opioid agent (or intravenous hypnotic agent) will be allowed in this group.

Opioid Anesthesia: In the opioid anesthetic group, intravenous sufentanil will be administrated during the organ procurement procedure. Continuous administration will be initiated after moving in the operating room (suggested dosage : 0,3 µg/kg/h) with supplemental dose if needed (at the discretion of the anesthesia team) and will be pursued until aortic clamping. No hypnotic drug administration will be allowed in this group.

Intraoperative brain-dead donor management: In all groups (experimental and control groups), neuromuscular blocking agents will be administered during the entire procedure, according to national guidelines. In all groups, hemodynamic management (use of vasoactive agents as vasopressors or anti-hypertensive drugs) will be done according to the discretion of the anesthesia team. In all groups, all the others aspects of the donor management will be not modified by the study protocol.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 of the anesthetic interventions evaluated in the trial: * Prior history of opioid or volatil anesthetic agents allergy. * Prior personal or family history of malignant hyperthermia or history of myopathy at risk of malignant hyperthermia. * Opposition to the research expressed by the patient during his or her lifetime and documented by the next of kin.

Primary outcome measure(s)

A hierarchical endpoint of hemodynamic stability during the organ procurement procedure — Operative time
Proportion of intraoperative time (between initial skin incision and aortic clamping) with a mean arterial blood pressure between 65 and 75 mmHg, between the volatile anesthetic group of brain-dead donors and : 1. The no anesthetic drug group of brain-dead donors. 2. The opioid anesthetic group of brain-dead donors.

Trial sites (1)

Facility	City	Region	Status
CHU Grenoble Alpes	Grenoble	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07166991 on ClinicalTrials.gov ↗ ← All trials in France