Impact of a Specific Anesthetic Strategy on Intraoperative Hemodynamic Stability During Organ Procurement in Brain Dead Donor: An Open-label Multicenter Randomized and Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- A hierarchical endpoint of hemodynamic stability during the organ procurement procedure
研究概览
简要总结
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.
详细描述
Brain-dead donors (BDD) remain the primary source of grafts for organ transplantation in France and worldwide. The main objective of BDD management, from the diagnosis of brain death in the intensive care unit (ICU) to organ procurement (OP) in the operating room, is to restore or maintain physiological homeostasis in order to preserve graft viability and improve long-term recipient outcomes. ICU management of potential BDD-particularly through donor management goals-has been shown to increase both the number and the quality of transplanted organs.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Volatile anesthetic group
Sevoflurane administration during the organ procurement procedure
干预措施: Volatile anesthetic (Drug)
Volatile anesthetic group
Sevoflurane administration during the organ procurement procedure
干预措施: Intraoperative brain-dead donor management (Other)
Opioid anesthetic group
Sufentanil administration during the organ procurement procedure
干预措施: Opioid Anesthesia (Drug)
Opioid anesthetic group
Sufentanil administration during the organ procurement procedure
干预措施: Intraoperative brain-dead donor management (Other)
No anesthetic drug group
No hypnotic (volatil anesthetics or intravenous anesthetics) or analgesic (opioid agents) drug administration during the organ procurement procedure
干预措施: Intraoperative brain-dead donor management (Other)
结局指标
主要结局
A hierarchical endpoint of hemodynamic stability during the organ procurement procedure
时间窗: 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.
次要结局
- Between-group comparaison of the total intraoperative volume of labile blood products(Operative time)
- 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 dose of catecholamines administered during the organ procurement procedure(Operative time)
- Between-group comparaison of the total intraoperative volume of vascular filling(Operative time)
- Between-group comparaison of the number of organs harvested and transplanted(24 hours)
- Between-group comparison of the rate of delayed graft function of the kidney(7 days post-transplant)
- Between-group comparison of the rate of primary lung graft dysfunction(72 hours)
- Between-group comparison of the rate of primary heart graft dysfunction(24 hours)
- Between-group comparison of the rate of primary liver graft dysfunction(7 days post-transplant)
- Describe the number of donor management goals achieved in the 12 hours prior and during the organ procurement procedure(24 hours)
- Between-group comparaison of the mean arterial blood pressure variability during the organ procurement procedure(Operative time)