A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9
研究概览
简要总结
This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •American Society of Anesthesiologists Class 1 or 2 or 3
- •>=18 years of age and of either sex
- •scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade
- •Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address
排除标准
- •expected difficult intubation due to anatomic malformations
- •expected transfer to intensive care unit after surgery
- •neuromuscular disorders affecting neuromuscular blockade
- •significant hepatic or renal dysfunction
- •require use of pneumatic tourniquet during surgery
- •(family) history of malignant hyperthermia
- •allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate
研究组 & 干预措施
Sugammadex
干预措施: sugammadex (Drug)
Neostigmine
干预措施: neostigmine (Drug)
结局指标
主要结局
Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9
时间窗: From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (height) of the 1st \& 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated complete recovery.
次要结局
未报告次要终点