The Influence of the Neuromuscular Blockade on Mask Ventilation; a Placebo Controlled, Randomized Trial With Three Different Dosages of Rocuronium (0.3 mg/kg, 0.6 mg/kg and 0.9 mg/kg)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of improved mask ventilation after rocuronium administration
研究概览
简要总结
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation. We will study different dosages of rocuronium; we assume that higher dosages of rocuronium will improve mask ventilation compared with lower dosages.
详细描述
Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and saline (placebo group) before starting with mask ventilation. We will grade mask ventilation based on various scores before and after rocuronium application. Afterwards patient's tracheas will be intubated. We assess risk factors for difficult mask ventilation.
We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ASA I-III
- •required tracheal intubation
- •informed consent
排除标准
- •known allergy against anesthetics
- •known difficult airway
研究组 & 干预措施
Rocuronium 0.6 mg/kg
Patients receive rocuronium 0.6 mg/kg
干预措施: Rocuronium 0.6 mg/kg (Drug)
Rocuronium 0.3 mg/kg
Patients receive rocuronium 0.3 mg/kg
干预措施: Rocuronium 0.3 mg/kg (Drug)
Rocuronium 0.9 mg/kg
Patients receive rocuronium 0.9 mg/kg
干预措施: Rocuronium 0.9 mg/kg (Drug)
Placebo
Patients receive saline
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of improved mask ventilation after rocuronium administration
时间窗: Two minutes after rocuronium administration
Graded with various scores
次要结局
未报告次要终点
研究者
Thomas Mencke
Prof. Dr. Thomas Mencke
University of Rostock