Anesthesia sTrategy foR Organ Procurement In braiN dEath

NCT07166991 | Recruiting Phase 3

• 1 other identifier: 38RC24.0238
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain-dead Organ Donors

Keywords

brain-dead organ donors; anesthesia; hemodynamic stability; sevoflurane; volatile anesthesia; sufentanil; opioid agents; organ procurement; organ harvesting; donor management

Outcome Measures

Primary Outcomes (1)

• A hierarchical endpoint of hemodynamic stability during the organ procurement procedure

  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.

  Operative time

Secondary Outcomes (15)

• Comparaison of the hemodynamic stability during the organ procurement procedure between the no anesthetic drug group and the opioid anesthetic group of brain-dead donors

  Operative time

• Between-group comparaison of the proportion of intraoperative time spent in hypotention

  Operative time

• Between-group comparaison of the proportion of brain-dead donors with a hemodynamic response at initial surgical incision

  Operative time

• Between-group comparaison of the proportion of brain-dead donors with a hemodynamic response to sternotomy

  Operative time

• Between-group comparaison of the mean arterial blood pressure variability during the organ procurement procedure

  Operative time

Other Outcomes (2)

• Comparaison the 1-year graft survival

  1 year

• Compare the number and type of rejection episodes that occurred for each type of transplanted organ

  1 year

Study Arms (3)

Volatile anesthetic group

EXPERIMENTAL

Sevoflurane administration during the organ procurement procedure

Drug: Volatile anesthetic; Other: Intraoperative brain-dead donor management

Opioid anesthetic group

ACTIVE COMPARATOR

Sufentanil administration during the organ procurement procedure

Drug: Opioid Anesthesia; Other: Intraoperative brain-dead donor management

No anesthetic drug group

ACTIVE COMPARATOR

No hypnotic (volatil anesthetics or intravenous anesthetics) or analgesic (opioid agents) drug administration during the organ procurement procedure

Other: Intraoperative brain-dead donor management

Interventions

Volatile anesthetic DRUG

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.

Volatile anesthetic group

Opioid Anesthesia DRUG

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.

Opioid anesthetic group

Intraoperative brain-dead donor management OTHER

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.

No anesthetic drug group; Opioid anesthetic group; Volatile anesthetic group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, France

RECRUITING

Related Publications (11)

• Fitzgerald RD, Dechtyar I, Templ E, Fridrich P, Lackner FX. Cardiovascular and catecholamine response to surgery in brain-dead organ donors. Anaesthesia. 1995 May;50(5):388-92. doi: 10.1111/j.1365-2044.1995.tb05989.x.

  PMID: 7793540 BACKGROUND

• Conci F, Procaccio F, Arosio M, Boselli L. Viscero-somatic and viscero-visceral reflexes in brain death. J Neurol Neurosurg Psychiatry. 1986 Jun;49(6):695-8. doi: 10.1136/jnnp.49.6.695.

  PMID: 3525756 BACKGROUND

• Wetzel RC, Setzer N, Stiff JL, Rogers MC. Hemodynamic responses in brain dead organ donor patients. Anesth Analg. 1985 Feb;64(2):125-8.

  PMID: 3882020 BACKGROUND

• Fitzgerald RD, Hieber C, Schweitzer E, Luo A, Oczenski W, Lackner FX. Intraoperative catecholamine release in brain-dead organ donors is not suppressed by administration of fentanyl. Eur J Anaesthesiol. 2003 Dec;20(12):952-6. doi: 10.1017/s0265021503001534.

  PMID: 14690096 BACKGROUND

• Elkins LJ. Inhalational anesthesia for organ procurement: potential indications for administering inhalational anesthesia in the brain-dead organ donor. AANA J. 2010 Aug;78(4):293-9.

  PMID: 20879630 BACKGROUND

• Souter MJ, Eidbo E, Findlay JY, Lebovitz DJ, Moguilevitch M, Neidlinger NA, Wagener G, Paramesh AS, Niemann CU, Roberts PR, Pretto EA Jr. Organ Donor Management: Part 1. Toward a Consensus to Guide Anesthesia Services During Donation After Brain Death. Semin Cardiothorac Vasc Anesth. 2018 Jun;22(2):211-222. doi: 10.1177/1089253217749053. Epub 2017 Dec 24.

  PMID: 29276852 BACKGROUND

• Boutin C, Vachiery-Lahaye F, Alonso S, Louart G, Bouju A, Lazarovici S, Perrigault PF, Capdevila X, Jaber S, Colson P, Jonquet O, Ripart J, Lefrant JY, Muller L; pour le groupe AzuRea. [Anaesthetic management of brain-dead for organ donation: impact on delayed graft function after kidney transplantation]. Ann Fr Anesth Reanim. 2012 May;31(5):427-36. doi: 10.1016/j.annfar.2011.11.027. Epub 2012 Apr 26. French.

  PMID: 22541983 BACKGROUND

• Perez-Protto S, Nazemian R, Matta M, Patel P, Wagner KJ, Latifi SQ, Lebovitz DJ, Reynolds JD. The effect of inhalational anaesthesia during deceased donor organ procurement on post-transplantation graft survival. Anaesth Intensive Care. 2018 Mar;46(2):178-184. doi: 10.1177/0310057X1804600206.

  PMID: 29519220 BACKGROUND

• Lele AV, Vail EA, O'Reilly-Shah VN, DeGraw X, Domino KB, Walters AM, Fong CT, Gomez C, Naik BI, Mori M, Schonberger R, Deshpande R, Souter MJ; MPOG Perioperative Clinical Research Committee. Identifying Variation in Intraoperative Management of Brain-Dead Organ Donors and Opportunities for Improvement: A Multicenter Perioperative Outcomes Group Analysis. Anesth Analg. 2025 Jan 1;140(1):41-50. doi: 10.1213/ANE.0000000000007001. Epub 2024 Jul 25.

  PMID: 39167559 BACKGROUND

• Lele AV, Nair BG, Fong C, Walters AM, Souter MJ. Anesthetic Management of Brain-dead Adult and Pediatric Organ Donors: The Harborview Medical Center Experience. J Neurosurg Anesthesiol. 2022 Jan 1;34(1):e34-e39. doi: 10.1097/ANA.0000000000000683.

  PMID: 32149890 BACKGROUND

• Champigneulle B, Neuschwander A, Bronchard R, Fave G, Josserand J, Lebas B, Bastien O, Pirracchio R; SFAR research network. Intraoperative management of brain-dead organ donors by anesthesiologists during an organ procurement procedure: results from a French survey. BMC Anesthesiol. 2019 Jun 15;19(1):108. doi: 10.1186/s12871-019-0766-y.

  PMID: 31202272 BACKGROUND

Study Officials

• Benoit CHAMPIGNEULLE, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoit CHAMPIGNEULLE, MD, PhD

CONTACT

+33476766879; BChampigneulle@chu-grenoble.fr

Anaïs ADOLLE

CONTACT

+33476766879; aadolle@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: September 11, 2025
• Study Start: February 17, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)