The Optimal Dose of Sevoflurane Via Anaconda® in Post-operative Patient Underwent Head & Neck Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomy
研究概览
简要总结
Sedation in the ICUs is very common. There is no ideal sedative yet, so research has been conducted to replace propofol and midazolam, which are the most commonly used sedatives in ICUs, by inhalation anesthetics. The investigators will sedate the patients who undergo head & neck surgery with tracheostomy for several days using sevoflurane, a kind of inhalation agent, via anesthetic conserving device.
The objective of this study is to confirm the end-tidal sevoflurane concentration for inducing moderate sedation (RASS -2~-3). In addition, the investigators compare the volatile sedation with the IV(intravenous) sedation to see if the volatile sedation could reduce the amount of post-operative opioid consumption.
- RASS: Richmond Agitation-Sedation Scale
- RASS: Richmond Agitation-Sedation Scale
详细描述
When patients, who need mechanical ventilation for several days after head & neck surgery, enters the ICU, the investigators induce moderate sedation (RASS -2~-3). End-tidal sevoflurane (etSEVO) concentration is adjusted to 0.5Vol% within 30 minutes. Sedation level is evaluated every 5 minutes. After 30 minutes, the investigators check that the sedation goal is achieved.
Following the up & down method, if the moderate sedation (RASS -2~-3) or the deep sedation (RASS -4~-5) is achieved at the etSEVO concentration of 0.5vol% after 30 minutes of sedation, the next patient's target etSEVO concentration is reduced to 0.4vol%. On the contrary to this, if only light sedation (RASS above -1) is achieved, the next patient's target etSEVO is increased to 0.6vol%. This process is repeated to find the appropriate etSEVO concentration at the beginning of sedation, which induces sedation of RASS -2~-3.
In retrospective analysis, the investigators compared the prospective study group with propofol intravenous sedation group.
* RASS: Richmond Agitation-Sedation Scale
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who needs sedation in the ICU for several days after head & neck surgery
- •ASA class I~III
- •Adult patients over 20 years old
- •Patients who can read and understand the informed consent
排除标准
- •Patients who do not agree to participate in the study
- •Past history or Family history of malignant hyperthermia
- •End stage renal disease (eGFR<30 or dialysis)
- •Moderate to severe liver disease (AST, ALT > 200IU/L)
- •Pregnant women
- •Patients who cannot read and understand the informed consent
研究组 & 干预措施
Sevoflurane group
Patients who are sedated using sevoflurane
干预措施: Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery (Drug)
Intravenous sedation group
Patients who are sedated using propofol
干预措施: Sedate using propofol. (Drug)
结局指标
主要结局
Optimal end-tidal sevoflurane concentration to induce moderate sedation of RASS -2~-3 in patients who undergo head & neck surgery with tracheostomy
时间窗: After the first 30 minutes after sedation with sevoflurane via anesthetic conserving device
Investigators will find the initial concentration of sevoflurane for proper sedation by the Dixon's up and down method.
次要结局
- Compare the sevoflurane group and the intravenous sedation group: Compare the remifentanil infusion dose(within the 3 days (plus of minus 3 days) after surgery)
- Compare the sevoflurane group and the intravenous sedation group: Compare the hospital day(within the 3 days (plus of minus 3 days) after surgery)
- Compare the sevoflurane group and the intravenous sedation group: Compare the incidence of delirium, hypotension(within the 3 days (plus of minus 3 days) after surgery)
- Compare the sevoflurane group and the intravenous sedation group: Compare the ICU stay(within the 3 days (plus of minus 3 days) after surgery)