drugset / Trial / NCT07166991
Anesthesia sTrategy foR Organ Procurement In braiN dEath
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-02-17
- Primary completion
- 2028-09-01
- Completion
- 2029-09-01
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sevoflurane | Other / unclassified | — | — |
| Comparator | Sufentanil | Other / unclassified | 0.3 ug/kg | Intravenous |
Indications
No indication recorded.