A Multi-center, Randomized, Parallel Group, Comparative, Active Controlled, Safety Assessor Blinded Trial in Adult Subjects Comparing Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Subjects Undergoing Short Surgical Procedures in Out-patient Surgicenters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine
研究概览
简要总结
A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects >=18 years of age;
- •ASA Class 1-3;
- •Subjects with a Body Mass Index (BMI) of < 35 kg/m^2 ;
- •Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;
- •Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);
- •Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;
- •Subjects who have given written informed consent.
排除标准
- •Subjects known to have ischemic heart disease or a history of myocardial infarction;
- •Subjects in whom a difficult intubation is expected because of anatomical malformations;
- •Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);
- •Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);
- •Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
- •Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL per min);
- •Subjects known or suspected to have significant hepatic dysfunction;
- •Subjects known or suspected to have a (family) history of malignant hyperthermia;
- •Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;
- •Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants, or other medications used during general anesthesia;
- •Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;
- •Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;
- •Female subjects who are pregnant;
- •Female subjects who are breast-feeding;
- •Subjects who have participated in a previous sugammadex trial;
- •Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 (P05700) unless pre-approved by the sponsor.
研究组 & 干预措施
Rocuronium - Sugammadex
Rocuronium - Sugammadex 4.0 mg/kg
干预措施: rocuronium (Drug)
Rocuronium - Sugammadex
Rocuronium - Sugammadex 4.0 mg/kg
干预措施: sugammadex (Drug)
Succinylcholine
Succinylcholine 1.0 mg/kg
干预措施: succinylcholine (Drug)
结局指标
主要结局
Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine
时间窗: Baseline and 5 minutes post dose
Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex
时间窗: Baseline and 5 minutes post dose
Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for "rocuronium - sugammadex" group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period).
次要结局
- Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine(Baseline and 2 minutes post dose)
- Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex(Baseline and 10 minutes post dose)
- Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex(Baseline and 2 minutes post dose)
- Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine(Baseline and 10 minutes post dose)
- Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine(Baseline and 15 minutes post dose)
- Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups(Up to 7 days post dose)
- Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex(Baseline and 15 minutes post dose)
- Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium(Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes))
- Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine(Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes))