A Multi-center, Randomized, Assessor-blinded, Placebo Controlled, Phase II, Parallel Dose-finding Trial in Male Subjects of ASA 1-2 to Assess the Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 When Administered After 0.6 mg.Kg-1 Esmeron® at 3, 5 or 15 Minutes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
研究概览
简要总结
This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants of ASA class 1 to
- •Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.
排除标准
- •Participants in whom a difficult intubation because of anatomical malformations is expected.
- •Participants known or suspected to have neuromuscular disorders and/or significant hepatic or 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 medication used during general anesthesia.
- •Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.
- •Participants who have already participated in this trial.
- •Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.
研究组 & 干预措施
Arm A. Placebo; given 3 minutes after Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Placebo (Drug)
Arm A. Placebo; given 3 minutes after Esmeron®
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm G. Placebo; given 5 minutes after Esmeron®
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Placebo (Drug)
Arm G. Placebo; given 5 minutes after Esmeron®
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm M. Placebo; given 15 minutes after Esmeron®
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Placebo (Drug)
Arm M. Placebo; given 15 minutes after Esmeron®
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Sugammadex (Drug)
Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
干预措施: Esmeron® (Drug)
结局指标
主要结局
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
时间窗: Up to 70 minutes following administration of study treatment
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
次要结局
- Mean Heart Rate at Baseline(Up to 45 minutes prior to study treatment administration)
- Mean Heart Rate at 2 Minutes Following Administration of Study Treatment(2 minutes following administration of study treatment)
- Mean Heart Rate at 30 Minutes Following Administration of Study Treatment(30 minutes following administration of study treatment)
- Mean Corrected QT Interval (QTc) at Baseline(Up to 45 minutes prior to study treatment administration)
- Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment(2 minutes following administration of study treatment)
- Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment(30 minutes following administration of study treatment)
- Number of Participants Experiencing an Adverse Event(Up to 7 days following administration of study treatment)