A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
研究概览
简要总结
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants at least 20 years but under 65 years of age;
- •Participants of American Society of Anesthesiologists (ASA) class 1-3;
- •Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
- •Participants scheduled for a surgical procedure in supine position;
- •Participants who had given written informed consent.
排除标准
- •Participants in whom difficult intubation was expected because of anatomical malformations;
- •Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
- •Participants known or suspected to have a (family) history of malignant hyperthermia;
- •Participants known or suspected to have an allergy to medications used during general anesthesia;
- •Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg^2+; based on the dose and time of administration;
- •Pregnant or lactating females;
- •Female participants of childbearing potential not using any birth control or using only hormonal contraception as birth control;
- •Participants who had already participated in trial CT 19.4.312, or in another trial with sugammadex;
- •Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.
研究组 & 干预措施
Sugammadex + Sevoflurane
After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
干预措施: Sugammadex (Drug)
Sugammadex + Sevoflurane
After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
干预措施: Rocuronium (Drug)
Sugammadex + Sevoflurane
After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
干预措施: Sevoflurane (Drug)
Sugammadex + Propofol
After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
干预措施: Sugammadex (Drug)
Sugammadex + Propofol
After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
干预措施: Rocuronium (Drug)
Sugammadex + Propofol
After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
干预措施: Propofol (Drug)
结局指标
主要结局
Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
时间窗: Up to 3 minutes after sugammadex administration
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 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \[loss of T4\] up to 1.0 \[no NMB\]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.
次要结局
- Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7(Up to 3 minutes after sugammadex administration)
- Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8(Up to 3 minutes after sugammadex administration)