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临床试验/NCT05216991
NCT05216991已完成不适用

The Role of Sugammadex and Quantitative Monitoring in "Fast-Track Anesthesia" During Liver Transplantation

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
97
试验地点
1
主要终点
Incidence of Postoperative Residual Weakness in the Recovery Room

研究概览

简要总结

The purpose of this research is to estimate the frequency of postoperative lasting muscle weakness in patients receiving Sugammadex after undergoing liver transplant surgery by using electromyographic device (EMG), such as TetraGraph.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients willing to participate and provide an informed consent.
  • Patients undergoing primary liver transplantation.

排除标准

  • Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
  • Patients with systemic neuromuscular diseases such as myasthenia gravis.
  • Patients with a known history of cerebrovascular accident (CVA).
  • Patients undergoing repeat liver transplantation or concomitant pancreas/kidney transplantation at the time of liver transplantation.
  • Patients admitted to the intensive care unit prior to liver transplantation.

结局指标

主要结局

Incidence of Postoperative Residual Weakness in the Recovery Room

时间窗: Approximately 10 minutes of surgery recovery period

Number of patients to experience postoperative residual weakness after receiving Sugammadex as standard of care for liver transplant surgery. Postoperative residual weakness is defined as train-of-four ratio (TOF) \<0.9. Train-of-four is a test used to measure the level of neuromuscular blockage through delivery of four consecutive stimuli to a nerve. Measurement of the muscle's response (number of twitches 1-4) to the stimuli indicates the degree of paralysis. This is measured by an EMG device placed on the thumb which is also part of standard of care for intraoperative assessment of muscle weakness. The ratio is calculated by comparing the amplitude of the fourth twitch to the first twitch. A TOF \<0.9 indicates residual weakness, a TOF equal to or greater than 0.9 indicates no residual weakness.

次要结局

  • ICU Admission(30 days)
  • Hospital Length of Stay(30 days)
  • Postoperative Pulmonary Complications(30 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Ross Renew, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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