Pharmacokinetics of Sugammadex for the Reversal of Moderate Neuromuscular Blockade in Patients During Renal Transplantation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Plasma Concentration of Sugammadex
研究概览
简要总结
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of rocuronium-induced moderate neuromuscular blockade in patients during renal transplantation
详细描述
34 patients undergoing renal transplantation or elective surgery are divided into 2 groups, including transplantation group (S group,n=17) and control group (C group, n=17). Patients age 18 to 65 and ASA glass I-III
Anaesthesia is induced and maintained with i.v. propofol and an opioid. Neuromuscular monitoring was performed at the adductor pollicis muscle with acceleromyography (TOF-Watch®SX, Organon Ireland Ltd, a division of Merck and Co., Dublin, Ireland). After calibration of the TOF-Watch®SX, an i.v. bolus dose of rocuronium 0.6 mg/kg is given for tracheal intubation, with maintenance doses 0.15mg/kg if T2 reappears to maintain moderate NMB Patients receive sugammadex 2 mg/kg i.v. for reversal when surgery finish and T2 reappears.
Venous blood samples of C group(within 12hours) and S group(within 48hours) are obtained before administration of Sug and at specified time points after administration of Sug to determine plasma concentration using HPLC-MS. Time from start of administration of Sug to recovery of TOF ratio to 0.7, 0.8, 0.9 and other clinical indicators are also recorded.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergo emergency renal transplantation under general anesthesia(CLCR≤30ml/min),or patients undergo elective surgery in supine position(CLCR≥80ml/min)
- •Patients age 18 to 65
- •ASA glass I-III
排除标准
- •patients suffering obstructive sleep apnea hypopnea syndrome or BMI≥28kg/m2
- •Pregnant or lactating women
- •neuromuscular disorders, hepatic dysfunction, cardiac disease, a history of malignant hyperthermia, or
- •allergic history during general anesthesia
- •patients receiving aminoglycoside antibiotics, anticonvulsants, magnesium,fusidic acid,toremifene and/or flucloxacillin
研究组 & 干预措施
Renal transplantation(S group)
n=17,CLCR≤30ml/min
干预措施: Sugammadex (Drug)
the control group
n=17, CLCR≥80ml/min
干预措施: Sugammadex (Drug)
结局指标
主要结局
Plasma Concentration of Sugammadex
时间窗: Samples were obtained pre-dose and at specified post-dose time points. C group: up to 12 hours post-dose, S group: up to 48 hours post-dose
venous blood samples were obtained
次要结局
- Adverse Event(Up to 2 days)
- Recovery Time and TOF ratio(up to 10 minutes from start of sugammadex)
研究者
bo xu
associate chief physician
Guangzhou General Hospital of Guangzhou Military Command