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临床试验/NCT05369949
NCT05369949尚未招募4 期

Effect of DEXmedetomidine and LOw Dose Sevoflurane on the Release of Serum Neurofilament Light in Congenital Cardiac Surgery.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain0 个研究点目标入组 150 人开始时间: 2023年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
150
主要终点
Concentration of serum Neurofilament Light

研究概览

简要总结

Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT).

Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.

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

盲法说明

The patient's parents will be informed of the study allocation in case they wish to know this, otherwise they are not supposed to be aware of group allocation. Persons who will assess the neurodevelopment outcome will not be aware of group allocation.

入排标准

年龄范围
1 Day 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients up to 3 years
  • Must undergo cardiac surgery with CPB

排除标准

  • Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
  • Preoperative cerebral hemorrhage, stroke or
  • Preoperative seizures
  • Abnormal preoperative cerebral ultrasound
  • Preoperative Extracorporeal Life Support
  • Preoperative sedated and intubated patients
  • Preterm newborns (< 32 W gestational age)
  • Newborns weighing < 2 kg
  • Patients with Williams-Beuren syndrome.

研究组 & 干预措施

DEX group

Experimental

Participants will receive an intraoperative and postoperative DEX infusion. In addition a low dose of sevoflurane will be administered.

干预措施: DEX group (Drug)

Control group

Active Comparator

Participants will receive general anesthesia with sevoflurane according to institutinal's practice.

干预措施: Control group (Other)

结局指标

主要结局

Concentration of serum Neurofilament Light

时间窗: At 24 hours postoperatively

To show a difference of change in serum NfL concentrations between both groups at 24h compared to baseline values.

次要结局

  • Renal function(7 days postoperatively)
  • Hospital stay(Up to 24 weeks)
  • Concentration of serum Neurofilament Light(At postoperative day 5)
  • Dose of Analgesics(72 hours postoperatively)
  • Time of exsudation(7 days postoperatively)
  • Neurodevelopmental outcome testing(6 months postoperatively)
  • Postoperative electroencephalogram registration(24 hours)
  • Concentration of regional cerebral oxygenation(Intraoperatively)
  • Pediatric Intensive Care Unit stay(Up to 24 weeks)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Momeni, MD, PhD

Deputy Anesthesiologist in Chief. MD,PhD

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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