"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- TOF ratio of 0.9
研究概览
简要总结
Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.
详细描述
The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general 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
- Triple (Participant, 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
- •ASA class I, II, and III
- •undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery
排除标准
- •patients undergoing emergency surgeries
- •pregnant patients
- •patients with end stage renal disease or chronic kidney disease(GFR less than 60)
- •patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
- •patients' refusal
- •patients with allergy to recuronium
研究组 & 干预措施
Group 1 : (NS)
Group 1 Drug combination:
patients receive half of the recommended dose of sugammadex plus dose of neostigmine"
- Sugammadex IV= -1 mg/kg( moderate NMB) or
- 2 mg/kg (deep NMB)
- neostigmine IV = 50mcg/kg
- glycopyrrolate 10 mcg/kg
干预措施: Sugammadex (Drug)
Group 1 : (NS)
Group 1 Drug combination:
patients receive half of the recommended dose of sugammadex plus dose of neostigmine"
- Sugammadex IV= -1 mg/kg( moderate NMB) or
- 2 mg/kg (deep NMB)
- neostigmine IV = 50mcg/kg
- glycopyrrolate 10 mcg/kg
干预措施: Neostigmine (Drug)
Group 1 : (NS)
Group 1 Drug combination:
patients receive half of the recommended dose of sugammadex plus dose of neostigmine"
- Sugammadex IV= -1 mg/kg( moderate NMB) or
- 2 mg/kg (deep NMB)
- neostigmine IV = 50mcg/kg
- glycopyrrolate 10 mcg/kg
干预措施: glycopyrrolate (Drug)
Group 2 : (S)
patients receive Full recommended dose of sugammadex
Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)
干预措施: Sugammadex (Drug)
结局指标
主要结局
TOF ratio of 0.9
时间窗: within 5 minutes
次要结局
- the time to return of TOF ratio to 0.9 and the time till extubation(within 10 minutes)
- Residual neuro-muscular blockade(within 10 to 180 mins)
研究者
Dr. Marie Awad
Professor of clinical Specialty
American University of Beirut Medical Center