A Multicenter Registry on the Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,100
- 试验地点
- 36
- 主要终点
- Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
研究概览
简要总结
Until recently, there was a lack of understanding and consensus among Chinese anesthesiologists how they should practice general anesthesia with volatile anesthetics, since there was no standard of inhalation practice. In August 2011, the Anesthesiology branch of the Chinese Medical Association launched the first version of Chinese Consensus of Standard Clinical Practice for Inhalation Anesthesia (Consensus) in order to standardize the practice in China.
The proposed registry is aimed to evaluate the current inhalation practice one year after the Consensus has been released, and related patient outcome. This registry evaluated sevoflurane anesthesia, including screening, induction, maintenance, emergence, and follow-up within 24 hours post-operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman, aged from 18 to 70 years old.
- •American Society of Anesthesiologists (ASA) physical status: I, II and III.
- •Surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA).
- •The type of surgery is either general surgery, or orthopedics, or gynecology.
- •The duration of anesthesia ranges from 1 to 5 hours.
排除标准
- •History of clinically significant cardiovascular, pulmonary, renal, hepatic or central nervous system or muscle disease.
- •Known hypersensitivity or history of unusual response to any halogenated anesthetics.
- •Personal or familial history of malignant hyperthermia.
- •Female patients who are either pregnant or breast feeding.
- •General anesthesia is administered with total intravenous anesthesia (TIVA) of propofol or sevoflurane maintenance combined with propofol continuous infusion during maintenance.
结局指标
主要结局
Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
时间窗: End of surgery
Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.
Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)
时间窗: 24 hours after end of surgery
Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).
次要结局
- Time to Eye Opening(From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes)
- Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus(During maintenance (up to 5 hours))
- Time to Extubation(From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes)
- Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)(Anesthetic duration between 1 to 5 hours)
- Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus(During maintenance (up to 5 hours))