Does Intraoperatively Administered Methylprednisolone Prolong the Neuromuscular Blocade Reversal Effect of Sugammadex?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Group Methylprednisolone
Patient in this group received general anaesthesia for surgical procedures. During the anesthesia management methylprednisolone was administered intravenously (1mg/kg) to the patients in this group. Also neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded.
干预措施: Neuromuscular monitorisation (Device)
Group Control
Patients who received general anaesthesia and endothracheal entubation but who did not recieved methyprednisone during general anaesthesia were enrolled in the study as control group. Neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded.
干预措施: Neuromuscular monitorisation (Device)
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
Basak Ceyda MECO
MD, DESA
Ankara University