Efficacy and Safety of Etomidate Combined with Propofol Intravenous Anesthesia During Hysteroscopic Procedures: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Apnea duration
研究概览
简要总结
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. Propofol is one of the most commonly used intravenous anesthetics in clinic for hysteroscopic procedures, however high dose propofol bring some potential clinical safety hazards.In this study, the feasibility and safety of Etomidate combined with propofol(1:2) as improved scheme for hysteroscopic surgery will be evaluated.
详细描述
Hysteroscopy is a gold standard method for evaluating the uterine cavity and diseases, which is gradually becoming a day-surgery in China. For hysteroscopic surgery using bipolar resectoscopes, hysteroscopic morcellators or shavers, it is considered efficient and safe to be performed under general anaesthesia, such as intravenous anesthesia. Propofol is one of the most commonly used intravenous anesthetics in clinic, however high dose propofol bring some potential clinical safety hazards, reducing respiratory rate and tidal volume, causing apnea or hypoxemia, and leading to hypoxia especially for obese and elderly patients. Propofol combined with etomidate as an improved scheme of intravenous anesthesia has been proved to have advantages in gastroendoscopy.In this study, the patients undergoing elective hysteroscopic surgery will be randomly assigned to two groups of intravenous anesthesia: Etomidate combined with propofol of 1:2 ratio (EP) versus Propofol (P). The sedation degree, respiratory related events (hypoxia, asphyxia incidence and maintenance time) and hemodynamic events，integrated pulmonary index (IPI) of the two groups will be evaluated to explore the feasibility and safety of the clinical application of EP mixture in hysteroscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective hysteroscopic surgery;
- •intravenous anesthesia;
- •normal reading and understanding ability
- •volunteer to participate
排除标准
- •serious complications such as heart failure, liver failure, pulmonary dysfunction, renal failure, etc.
- •predictable difficult airway
- •high risk of reflux aspiration
- •allergy to propofol or etomidate
- •already participated in other clinical trials within three months before admission
- •unwilling to cooperate
研究组 & 干预措施
Etomidate combined with propofol（EP）
0.2ml/kg IV
干预措施: Sedation Etomidate combined with propofol (Drug)
Propofol（P）
0.2ml/kg IV
干预措施: Sedation Propofol (Drug)
结局指标
主要结局
Apnea duration
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time duration from the disappearance to the recovery of spontaneous breathing, record in seconds.
Modified observer's assessment of alert /sedation scores (MOAAS scores)
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Modified observer's assessment of alert /sedation score 0-2 as effective anesthesia for hysteroscopic procedures.The MOAAS scores is a 6-point scale that assesses the responsiveness of patients and coincides with the ASA continuum of sedation. A patient with a score of 5 responds readily to name spoken in a normal tone, 4 lethargic response to name spoken in a normal tone, 3 responds only after the name is called loudly and/or repeatedly, 2 responds only after mild prodding or shaking, 1 responds only after painful trapezius squeeze, and 0 does not respond to painful trapezius squeeze (0 to 1 deep sedation, 2 to 4 moderate sedation, and 5 minimal sedation or alert).
次要结局
- Heart rate (HR)(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Pulse oxygen saturation (SpO2)(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Blood Pressure(BP)(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)
- Incidence of manual ventilation intervention(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)