A Comparative Study of the Efficacy and Safety of Etomidate Compared to Propofol in Gastric Endoscopic Submucosal Dissection: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Respiratory adverse event
研究概览
简要总结
During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-80
- •American Society of Anesthesiologists Physical Status Classification System (ASA) score of I, II, III
- •Scheduled endoscopy
排除标准
- •Pregnancy
- •Previous study History of hypersensitivity to drugs or substances containing soy or egg ingredients
- •Those who think that tracheal intubation will be difficult
- •Obstructive sleep apnea
- •History of side effects from previous sedatives
- •People with severe liver disease, kidney disease, or heart disease
- •Those who want a non-sleeping endoscope
- •A person who refuses to provide consent
- •SBP < 80mmHg or SpO2 < 90%
- •Patients with adrenocortical dysfunction, chronic steroid users
研究组 & 干预措施
Propofol
induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol
干预措施: Propofol Injection (Drug)
Etomidate
induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate
干预措施: Etomidate Injection (Drug)
结局指标
主要结局
Respiratory adverse event
时间窗: during gastric endoscopic submucosal dissection
the number and proportion of cases of respiratory depression
次要结局
- ESD clinical outcomes(From enrollment to the first clinic visit (within 60 days))
- Adverse events and procedure interruptions(during gastric endoscopic submucosal dissection)
- Sedation-related profile(From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml))
- Satisfaction assessment(From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score))
- Hemodynamic changes(From date of randomization until the date of first documented progression (up to 2 hours))
- Factors associated with adverse events(From date of randomization until the date of first documented progression (up to three days))
研究者
Keum, Bo Ra
Professor
Korea University Anam Hospital