A Multi-center, Open Label Trial, to Show Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex Administered at a Depth of Neuromuscular Blockade of 1-2 PTC Induced by Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 164
- 主要终点
- Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
研究概览
简要总结
The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using
- •rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).
- •For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.
排除标准
- •Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the
- •(family of) study/sponsor staff.
研究组 & 干预措施
Sugammadex in Caucasian Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
干预措施: Sugammadex (Drug)
Sugammadex in Chinese Subjects
At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
干预措施: Sugammadex (Drug)
结局指标
主要结局
Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
时间窗: Start of administration of sugammadex to recovery from neuromuscular blockade
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. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery. Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary.
次要结局
- Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7(Start of administration of sugammadex to recovery from neuromuscular blockade)
- Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8(Start of administration of sugammadex to recovery from neuromuscular blockade)