Anesthesia sTrategy foR Organ Procurement In braiN dEath
NCT ID: NCT07166991
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
270 participants
INTERVENTIONAL
2025-09-01
2029-09-01
Brief Summary
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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.
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Detailed Description
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In contrast, anesthetic management of BDD during OP is less standardized, although surgical manipulation may jeopardize donor homeostasis. Hemodynamic responses to surgical stimuli (e.g., incision and visceral manipulation), such as tachycardia and marked increases in arterial blood pressure, are well described and result from preserved spinal reflexes. These reflexes, and the vasoactive drugs administered to counteract them, may cause intraoperative hemodynamic instability potentially detrimental to grafts.
Opioids have been proposed to attenuate these responses, but they have proven ineffective in suppressing catecholamine release induced by nociceptive surgical stimulation. Volatile anesthetics (in addition to potential protective effects against ischemia-reperfusion injury) may more effectively blunt these reflex responses. However, their benefits during OP in BDD have not been demonstrated. In the absence of evidence, retrospective studies and surveys in the USA and France report wide heterogeneity in anesthetic strategies used during graft harvesting. Volatile anesthetics and opioids remain the most common agents despite the lack of proven benefit compared with no anesthetic use.
This randomized controlled trial is designed to evaluate whether volatile anesthetics (sevoflurane) improve intraoperative hemodynamic stability during OP in BDD, compared with either no anesthetic use or opioid (sufentanil) administration. The hypothesis is that halogenated agents, by blunting spinally mediated hemodynamic responses to surgical stimuli, will provide greater intraoperative hemodynamic stability than no anesthetic or an opioid-based strategy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Volatile anesthetic group
Sevoflurane administration during the organ procurement procedure
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.
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.
Opioid anesthetic group
Sufentanil administration during the organ procurement procedure
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.
No anesthetic drug group
No hypnotic (volatil anesthetics or intravenous anesthetics) or analgesic (opioid agents) drug administration during the organ procurement procedure
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Benoit CHAMPIGNEULLE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Central Contacts
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References
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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.
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.
Wetzel RC, Setzer N, Stiff JL, Rogers MC. Hemodynamic responses in brain dead organ donor patients. Anesth Analg. 1985 Feb;64(2):125-8.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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38RC24.0238
Identifier Type: -
Identifier Source: org_study_id
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