Serum Tryptase Concentration During General Anaesthesia With Rocuronium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 主要终点
- tryptase
研究概览
简要总结
Rocuronium is a aminosteroid structured, non-depolarizing neuromuscular blocking agents (NMB). Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Determinations of serum tryptase concentrations are interdisciplinary recommended in diagnosis of its adverse reactions. No studies have been performed to explain specific role of rocuronium doses on serum tryptase values. The aim of this study was to investigate the potential effect of rocuronium on serum tryptase concentrations.
详细描述
The greatest risk of hypersensitivity occurs during anesthesia for female patients and it is connected with the induction phase using skeletal muscle relaxants . Epidemiological data presents that the frequency of hypersensitivity reactions caused by rocuronium have been increased. Due to the multiple advantages reports of triggering allergic or hypersensitivity reactions caused by rocuronium create doubts about the safety of application .
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
- Single (Investigator)
盲法说明
qualification according surgical operation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia
排除标准
- •steroid therapy, allergy in medical history, mastocytosis
研究组 & 干预措施
anaesthesia with rocuronium
rocuronium is used during anaesthesia
干预措施: Rocuronium (Drug)
anaesthesia with rocuronium
rocuronium is used during anaesthesia
干预措施: general volatile anaesthesia (Drug)
anaesthesia without rocuronium
during anaesthesia rocuronium is not used
干预措施: general volatile anaesthesia (Drug)
结局指标
主要结局
tryptase
时间窗: up to 40 minutes after surgery
serum tryptase concentration
次要结局
未报告次要终点