A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- Mean 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 purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •American Society of Anesthesiologists (ASA) Class 1 to 3
- •18 years of age or older
- •Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
- •Scheduled for surgery in supine position
- •Given written informed consent
排除标准
- •Participants in whom a difficult intubation is expected due to anatomical malformations
- •Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
- •Participants known or suspected to have a (family) history of malignant hyperthermia
- •Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medications used during surgery
- •Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
- •Female participants who are pregnant or breast-feeding
- •Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), intrauterine device (IUD), abstinence]
- •Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
- •Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305
研究组 & 干预措施
Participants 18 to 64 years old
Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
干预措施: Sugammadex (Drug)
Participants 18 to 64 years old
Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
干预措施: Rocurium (Drug)
Participants 65 to 74 years old
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
干预措施: Sugammadex (Drug)
Participants 65 to 74 years old
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
干预措施: Rocurium (Drug)
Participants 75 years and older
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
干预措施: Sugammadex (Drug)
Participants 75 years and older
Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.
干预措施: Rocurium (Drug)
结局指标
主要结局
Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
时间窗: up to 10 minutes from start of sugammadex
Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.
次要结局
- Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation(Prior to Transfer to the Recovery Room After Extubation (up to 24 hours))
- Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room(Prior to Discharge from Recovery Room (up to 24 hours))
- Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7(up to 10 minutes from start of sugammadex)
- Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8(up to 10 minutes from start of sugammadex)
- Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation(Prior to Transfer to the Recovery Room After Extubation (up to 24 hours))
- Participants Level of Consciousness Prior to Discharge From Recovery Room(Prior to Discharge from Recovery Room (up to 24 hours))
- Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation(Prior to Transfer to the Recovery Room After Extubation (up to 24 hours))
- Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room(Prior to Discharge from Recovery Room (up to 24 hours))