Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- incidence of vocal cord injuries
研究概览
简要总结
Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.
详细描述
Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.
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
- •orotracheal intubation
- •surgery of the ear
- •written consent
- •ASA I-III
排除标准
- •preexisting pathologies of the vocal cords
- •difficult airway
研究组 & 干预措施
Sevoflurane
Anesthesia was maintained with sevoflurane during surgery.
干预措施: Sevoflurane (Drug)
Anesthesia with propofol
Anesthesia was maintained with propofol during surgery.
干预措施: propofol (Drug)
结局指标
主要结局
incidence of vocal cord injuries
时间窗: 24h after surgery
assessed by stroboscopy
次要结局
- incidence of hoarseness(24h after surgery)
研究者
Thomas Mencke
Thomas Mencke
University of Rostock