Anesthesia of Endolaryngeal Laser Surgery and Perioperative Side Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- oxygenization
研究概览
简要总结
Investigators analyze the anesthesia of the endolaryngeal laser surgery in patients with smoking with or without monitoring of depth of anesthesia (bispectral index)
详细描述
All participants are informed about the investigation and are signed the Informed Consent before anesthesia. The study takes place at the Department of Otorhinolaryngology, University of Pecs, Hungary. Between June 2021 and May 2022 ASA I or II patients aged 18-65 years, scheduled for elective endolaryngeal laser surgery with TCI (target-controlled infusion, propofol). Exclusion criteria are epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease. Participants are randomized to two anesthetic groups, anesthesia with or without bispectral index monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
anesthesia with target-controlled infusion (propofol) with or without the depth of anesthesia (bispectral index) monitoring and evaluation of vital parameters, side effects, and postoperative delirium
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •endolaryngeal laser surgery with target-controlled anesthesia
排除标准
- •epilepsy, psychiatric illness, cerebrovascular or congenital neuromuscular disease
研究组 & 干预措施
target-controlled infusion (propofol) with depth of anesthesia monitoring
In this group, propofol dosing is adjusted with bispectral index monitoring.
干预措施: bispectral index monitoring (Other)
target-controlled infusion (propofol) without depth of anesthesia monitoring
In this group, propofol dosing is adjusted without bispectral index monitoring.
干预措施: bispectral index monitoring (Other)
结局指标
主要结局
oxygenization
时间窗: through study completion, an average of 1 year
oxygen saturation (%)
cardiac function
时间窗: through study completion, an average of 1 year
pulse rate (beats/minute)
ventilation
时间窗: through study completion, an average of 1 year
end-tidal carbon-dioxide (mmHg)
depth of anesthesia
时间窗: through study completion, an average of 1 year
bispectral index level (number between 1-100), the target intraoperative level 40-60, lower and higher are worse
circulation
时间窗: through study completion, an average of 1 year
blood pressure (mmHg)
次要结局
- cognitive functions(through study completion, an average of 1 year)
研究者
Timea Bocskai
senior lecturer
University of Pecs