Sugammadex Versus Neostigmine After Rocuronium Infusion During Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX.
研究概览
简要总结
Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization.
Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex.
No one study compared sugammadex versus neostigmine after rocuronium infusion during liver transplantation.
详细描述
It is known that major abdominal surgery is associated with increased risk of morbidity and postoperative mortality. The complexity and the duration of the procedure as well as the failure to antagonize neuromuscular blocking agents at the end of surgical procedure are risk factors for postoperative complications.
Muscle relaxation plays an important role that is to facilitate intubation and to allow a better surgical condition. For this reason it is necessary to maintain, during the surgery, a deep neuromuscular block.
Deep block at the level of the adductor muscle of the thumb is obtained by measuring 1-2 responses during post-tetanic stimulation (the so-called Post-Tetanic Count or PTC).
The maintenance of a deep neuromuscular block requires further doses of neuromuscular blockers and, therefore, the need of long recovery times regardless of the drug used.
Pharmacodynamics and pharmacokinetics of neuromuscular blocking and reversals commonly used in clinical practice can undergo significant changes due to the presence of alterations in organ function such as hepatic and renal insufficiency. In these patients we see more frequent adverse events such as prolonged neuromuscular blockade and postoperative residual curarization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •American Society of Anesthesiology status (ASA) III
- •Ability to give a written informed consent
- •Liver transplantation
排除标准
- •Any allergy to medications involved in the study
- •Any disease involving neuromuscular transmission
- •Any therapy with toremifene, flucloxacillin or fusidic acid
- •Renal disease with glomerular filtration rate less than 30 ml/min/1.73m2
- •Hyperthermia maligna
- •Anticonceptional therapy
- •Pregnancy
- •Core body temperature less than 35°C or skin temperature less than 32°C at the end of surgery
研究组 & 干预措施
sugammadex
at the end of surgery administration of 2 mg/kg of sugammadex after the third T2 twitch at Train of Four (TOF) stimulation
干预措施: sugammadex (Drug)
neostigmine
at the end of surgery administration of 50 mcg/kg of neostigmine after the third T2 twitch at Train of Four (TOF) stimulation
干预措施: Neostigmine (Drug)
结局指标
主要结局
Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX.
时间窗: 30 minutes
次要结局
- Any episode PORC (defined as TOF ratio less than 0.9) within 20 minutes after extubation of the patient using TOF-Watch SX.(20 minutes)
研究者
Livia Pompei
MD
Azienda Ospedaliera S. Maria della Misericordia
