Effect of Dexamethasone on the Action of Sugammadex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex
研究概览
简要总结
This study aims to investigate the possible clinical effect of dexamethasone on the action of sugammadex when it is administered to reverse deep neuromuscular blockade caused by rocuronium in laparoscopic cholecystectomies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 18-70 years
- •laparoscopic cholecystectomy
- •operation < 3 hours
排除标准
- •age <18 or >70 years old
- •ASA physical status >3
- •central nervous system diseases
- •severe psychiatric disorders under treatment
- •cognitive dysfunction
- •known or suspected allergy to the administered drugs
- •operations > 3 hours
- •surgical intraoperative complications-open cholecystectomy
- •severe renal or liver disease
- •diabetes melitus
- •immunosuppressed patients
- •chronic immunosuppresant therapy (corticosteroids or other drugs)
- •all contraindications to corticosteroids administration
- •patiens on chronic use of opioids
研究组 & 干预措施
dexamethasone
Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
干预措施: Dexamethasone (Drug)
dexamethasone
Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
干预措施: sugammadex (Drug)
normal saline
Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
干预措施: Normal Saline (Drug)
normal saline
Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
干预措施: sugammadex (Drug)
结局指标
主要结局
Time to train-of-four (TOF) ratio of 0.9 since administration of sugammadex
时间窗: minutes after administration of sugammadex (0 to 30 minutes)
measurement of time after administration of the reversal agent (sugammadex) to achieve train-of-four (TOF0 ratio of 0.9 (up to 30 minutes)
次要结局
- Postoperative pain(1, 6, 12, 24 hours postoperatively)
- Postoperative nausea and vomiting(1, 6, 12, 24 hours postoperatively)
研究者
Chrysanthi Batistaki
Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece
Attikon Hospital