Prospective, Single-blind Study Investigating the Effect of Sevoflurane and Desflurane, Agents Used in Patients on the MEP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Middle ear pressure
研究概览
简要总结
The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in patients who do not have any ear pathology and undergo surgery under general anesthesia, on the MEP.
详细描述
Studies reported that inhalation agents are more likely to have impacts on the middle ear pressure compared to intravenous anesthetic agents. Despite numerous studies comparing the effects of inhalation agents on the middle ear pressure, this is the first clinical trial in which end tidal carbon dioxide and effects of sevoflurane and desflurane, along with other anesthetic analgesic agents used, on the middle ear pressure were compared. Our purpose in this study was to investigate the effect of sevoflurane and desflurane, inhalation agents used in patients who do not have any ear pathology and undergo non-ear surgery under general anesthesia, on the middle ear pressure.
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)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(ASA) II-III physical status
- •elective inguinal hernia
- •lower extremity surgery
- •general anesthesia
- •supine position
排除标准
- •nasal septum,
- •adenotonsillar hypertrophy,
- •perforated tympanic membrane,
- •middle ear pathology
- •receive medications for middle ear pressure .
研究组 & 干预措施
sevoflurane 2%, 1 MAC
Maintenance of anesthesia was provided with 2% sevoflurane in S Group, and 6-9% desflurane in D Group, with 50% air /oxygen mixture and fresh gas flow at 4 l/min in both groups.
干预措施: Sevoflurane (Drug)
Desfluran 6-9% 1MAC
Maintenance of anesthesia was provided with 2% sevoflurane in S Group, and 6-9% desflurane in D Group, with 50% air /oxygen mixture and fresh gas flow at 4 l/min in both groups.
干预措施: desflurane, (Drug)
结局指标
主要结局
Middle ear pressure
时间窗: postoperative 30th minutes
Tympanometric measurements were performed and recorded for each ear preoperatively, at intraoperative 5th, 10th and 15th minutes and postoperative 10th and 30th minutes. Normal middle ear pressure ranges between -200 and +200 decapascals (daPa). Treatment-Related Adverse Events, Ear and labyrinth disorder Assessed by CTCAE v4.0
次要结局
未报告次要终点
研究者
Sevtap Hekimoglu Sahin
Clinical Professor
Trakya University