A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of a Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9
研究概览
简要总结
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sugammadex
Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
干预措施: Sugammadex (Drug)
Sugammadex
Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9
时间窗: Up to approximately 30 minutes following administration of study treatment
Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
次要结局
- Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8(Up to approximately 15 minutes following administration of study treatment)
- Clinical Assessment of Recovery - Participant's Level of Consciousness(Up to 24 hours)
- Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL)(Up to 24 hours)
- Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7(Up to approximately 10 minutes following administration of study treatment)
- Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW)(Up to 24 hours)