A Multi-center, Parallel-group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of 4.0 mg/kg Sugammadex Administered at 1-2 PTC in Subjects With Normal or Severely Impaired Renal Function
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Time to Recovery of the T4/T1 Ratio to 0.9.
研究概览
简要总结
The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.
详细描述
The results of previous trials showed that the safety profile of sugammadex
observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. Reoccurrence of neuromuscular blockade was not observed, and sugammadex was safe and generally well tolerated in subjects with severe renal impairment. In a previous trial, subjects (n=15) with severe renal impairment received a dose of 2.0 mg.kg-1 of sugammadex. The effects of the other proposed recommended dose for routine reversal, 4.0 mg.kg-1, on efficacy, safety and pharmacokinetics had not been studied thus far in subjects with severe renal impairment. The objectives of this trial were to assess equivalence with respect to the efficacy of sugammadex in subjects with normal renal function or severe renal impairment, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.
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
- •At least 18 years of age
- •ASA class 1-3
- •Creatinine clearance (CLcr) < 30 mL/min and no anticipated clinical
- •indication for high flux hemodialysis during first 24 hours after
- •sugammadex administration (for renally impaired group) or CLcr >= 80
- •mL/min (for control group)
- •Scheduled for a surgical procedure under general anesthesia with propofol
- •requiring neuromuscular relaxation with the use of rocuronium
- •Scheduled for a surgical procedure in supine position
- •Written informed consent
排除标准
- •Subjects known or suspected to have neuromuscular disorders impairing
- •neuromuscular blockade and/or significant hepatic dysfunction
- •Subjects scheduled for renal transplant surgery
- •Subjects known or suspected to have a (family) history of malignant
- •hyperthermia
- •Subjects known or suspected to have an allergy to narcotics, muscle
- •relaxants or other medication used during general anesthesia
- •Subjects receiving fusidic acid, toremifene and/or flucloxacillin
- •Subjects who have already participated in a sugammadex trial
- •Subjects who have participated in another clinical trial, not pre-approved
- •by the sponsor, within 30 days of entering into 19.4.328 (P05769)
- •Female subjects who are pregnant
- •Female subjects who are breast-feeding
研究组 & 干预措施
Participants with severe renal impairment
Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
干预措施: sugammadex (Drug)
Participants with normal renal function
Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
干预措施: sugammadex (Drug)
结局指标
主要结局
Time 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.
次要结局
- Time to Recovery of the T4/T1 Ratio to 0.8(start of administration of sugammadex to recovery from neuromuscular blockade)
- Time to Recovery of T4/T1 Ratio to 0.7(start of administration of sugammadex to recovery from neuromuscular blockade)