The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Entropy
研究概览
简要总结
Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.
详细描述
Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.
Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.
Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ASA I-III scheduled for elective major surgery
- •both sexes
排除标准
- •patients hypertensive
- •treated with antihypertensive drugs
研究组 & 干预措施
sugammadex 2 mg/kg
2 mg/kg of sugammadex are given when a response of two counts of train of four are present
干预措施: sugammadex (Drug)
4 mg/kg of sugammadex
4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears
干预措施: Sugammadex 4 mg/kg (Drug)
Sugammadex 16 mg/kg
Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium
干预措施: Sugammadex 16mg/kg (Drug)
结局指标
主要结局
Entropy
时间窗: every three minutes
次要结局
- hemodynamics(every three minutes)
研究者
Argyro Fassoulaki
MD, PhD, DEAA
University of Athens