A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
研究概览
简要总结
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg 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
- 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
- •Is of American Society of Anesthesiologists (ASA) 1 - 4;
- •Is above or equal to the age of 18;
- •Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
- •Scheduled for surgical procedure in supine position;
- •Given written informed consent.
排除标准
- •Participants in whom a difficult intubation because of anatomical malformations was expected;
- •Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
- •Is known or suspected to have a (family) history of malignant hyperthermia;
- •Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- •Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
- •Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- •Had already participated in a sugammadex trial;
- •Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P
- •Females who are pregnant:
- •Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
- •Females who were breast-feeding.
研究组 & 干预措施
Vecuronium + Sugammadex
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
干预措施: Sugammadex (Drug)
Rocuronium + Sugammadex
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
干预措施: Sugammadex (Drug)
Rocuronium + Neostigmine
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
干预措施: Neostigmine (Drug)
Vecuronium + Neostigmine
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
干预措施: Neostigmine (Drug)
结局指标
主要结局
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
时间窗: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth 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 (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
次要结局
- Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7(Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7)
- Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8(Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8)
- Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation(Day 1)
- Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room(Day 1)