跳至主要内容
临床试验/NCT02697929
NCT02697929已完成不适用

Sugammadex Versus Neostigmine After Rocuronium Infusion During Liver Transplantation

Azienda Ospedaliera S. Maria della Misericordia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

发起方
Azienda Ospedaliera S. Maria della Misericordia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Livia Pompei

MD

Azienda Ospedaliera S. Maria della Misericordia

研究点 (1)

Loading locations...

相似试验

Sugammadex/Neostigmine and Liver Transplantation | 临床试验