The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The recovery time of the neuromuscular blockade in both groups
研究概览
简要总结
The effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can reduce the length of PACU stay.
详细描述
A randomized clinical trial was conducted between 18 December 2020 and 21 April 2021.A total of forty patients who underwent simultaneous kidney and pancreas transplantation surgery.All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA). Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB. The neuromuscular blockade was monitored via a peripheral nerve stimulator TOF watch SX acceleromyography. Patients received adequate doses of rocuronium to maintain an enough neuromuscular blockade during the whole surgery. Serum creatinine (CREA), blood glucose (Glu) levels were measured at T0, 8h(T1), 12h(T2), 36h(T3), 60h(T4), 84h(T5), and 108h(T6), and blood pressure (MAP), heart rate (HR), blood oxygen saturation (SpO2) and stay time in PACU were recorded.
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
- None
盲法说明
This randomized, prospective, controlled, double-blind trial was conducted at the second affiliated hospital of Guangzhou Medical University,China
入排标准
- 年龄范围
- 25 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 25 and 62 years
- •body mass index （BMI）of 18.5-24.9kg/m2
- •American Society of Anesthesiologists (ASA) score from I to III.
排除标准
- •history of allergy to narcotic drugs and other drugs
- •cardiopulmonary insufficiency
- •congestive heart failure
- •neuromuscular disease，such as myasthenia gravis
- •severe liver dysfunction
- •hyperkalemia
- •history of malignant hyperfever .
研究组 & 干预措施
Sugammadex
In the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected .
干预措施: Sugammadex (Drug)
Sugammadex
In the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected .
干预措施: Normal saline (Drug)
Normal Saline
the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected .
干预措施: Sugammadex (Drug)
Normal Saline
the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected .
干预措施: Normal saline (Drug)
结局指标
主要结局
The recovery time of the neuromuscular blockade in both groups
时间窗: up to 3 months
Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB
次要结局
- Mean blood pressure (MAP)(up to 3 months)
- Heart rate(HR),time（T）,hour(h)(up to 3 months)
- blood oxygen saturation (SpO2),time（T）,hour(h)(up to 3 months)