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临床试验/NCT02025309
NCT02025309已完成4 期

Does Intraoperatively Administered Methylprednisolone Prolong the Neuromuscular Blocade Reversal Effect of Sugammadex?

Ankara University2 个研究点 分布在 2 个国家目标入组 164 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
164
试验地点
2
主要终点
Train of four ratio 0.9

研究概览

简要总结

Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Likewise, some other steroid hormones and drugs like flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in this study we aimed to compare the recovery times from recuronium-induced muscle relaxation after reversal with sugammadex between patients who receive intraoperative methylprednisolone or not.

After institutional review board (IRB) approval and informed consent, 100 patients will be enrolled in this prospective, single center, controlled study. Anaesthesia will be induced with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance. Patients will be divided randomly into two groups methylprednisolone administered group and control group respectively). Neuromuscular blockade will be monitored using calibrated acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9 will be compared in both groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient operated under general anesthesia and endothracheal intubation.
  • 18-65 years old

排除标准

  • Neuromuscular desease
  • Renal desease
  • Liver failure
  • Hypersensitivity to the medications used in the study.
  • Being on steroid medication
  • Pregnanacy, Lactation

结局指标

主要结局

Train of four ratio 0.9

时间窗: During the procedure period.

At the end of the procedure, train of four (TOF) monitorisation was continued and once rocuronium-induced neuromuscular blockade recovered spontaneously to TOF-count-two, all patients received 2.0 mg/kg of sugammadex. Then, neuromuscular monitoring was continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time needed for the recovery of TOF to 0.9 was noted.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Basak Ceyda MECO

MD, DESA

Ankara University

研究点 (2)

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