A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.Kg-1 Rocuronium Followed by 16 mg.Kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.Kg-1 Succinylcholine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration
研究概览
简要总结
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
- •18 to 65 years of age (inclusive);
- •Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
- •Scheduled for surgery in supine position;
- •Body mass index (BMI) < 30;
- •Given written informed consent.
排除标准
- •Has ischemic heart disease or history of myocardial infarction within the last year;
- •May experience difficult intubation due to anatomical malformations;
- •Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
- •Known or suspected family history of malignant hyperthermia;
- •Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
- •Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
- •Individuals in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- •Females who are pregnant or breast-feeding;
- •Females of childbearing potential who are not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
- •Has already participated in a sugammadex trial including Protocol 19.4.303.
研究组 & 干预措施
Rocuronium + Sugammadex
Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex.
干预措施: Sugammadex (Drug)
Rocuronium + Sugammadex
Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex.
干预措施: Rocuronium (Drug)
Succinylcholine
Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.
干预措施: Succinylcholine (Drug)
结局指标
主要结局
Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration
时间窗: Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine
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 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.
次要结局
- Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration(Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine)
- Number of Participants Experiencing General Muscle Weakness(Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine)
- Level of Consciousness: Number of Participants Awake and Oriented(Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine)
- Level of Consciousness: Number of Participants Arousable With Minimal Stimulation(Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine)
- Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation(Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine)
- Number of Participants Able to Perform 5-Second Head Lift(Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine)