Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- incidence of vocal cord injuries
研究概览
简要总结
Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.
详细描述
We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •ear-nose-throat surgery
- •orotracheal intubation for surgery of the ear
- •ASA I-III
排除标准
- •allergy against the study drugs
- •patients with a known or suspected difficult airway
- •diseases of the larynx
研究组 & 干预措施
sevoflurane 1,0
sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC
干预措施: sevoflurane 1,0 (Drug)
sevoflurane 1,2
sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC
干预措施: sevoflurane 1,2 (Drug)
sevoflurane 1,4
sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC
干预措施: sevoflurane 1,4 (Drug)
结局指标
主要结局
incidence of vocal cord injuries
时间窗: 24 hours after tracheal intubation
次要结局
- incidence of soar throat(24, 48, and 72 hours after tracheal intubation)
- incidence of hoarseness(24, 48, and 72 hours after tracheal intubation)
研究者
Thomas Mencke
Clinical Associate Professor Dr Thomas Mencke
University of Rostock