The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 主要终点
- Heart rate
研究概览
简要总结
To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.
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
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 and 35 years
- •American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
- •Singleton pregnancy and the gestational period is 6 to 8 weeks
- •Expected operation duration is within 60 minutes
- •The body weight should be within 15% around the standard weight
- •Signed informed consent form
排除标准
- •Serious cardiac, cerebral, liver, kidney, lung, endocrine disease
- •Upper respiratory infections within 4 weeks
- •Long use of hormone or history of adrenal suppression
- •History of use of glucocorticoids, aprotinin or immunosuppressant
- •Manifestation of immunodeficiency
- •History of use of sedatives or opiates
- •Needs of Neuromuscular blocker (except intubation)
- •Allergy to trial drug or other contraindication
- •Pregnant or breast-feeding women
- •Attended other trial past 30 days
研究组 & 干预措施
Group A
In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: pentazocine (Drug)
Group A
In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: propofol (Drug)
Group A
In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: Etomidate (Drug)
Group B
In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: pentazocine (Drug)
Group B
In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: propofol (Drug)
Group B
In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: Etomidate (Drug)
Group C
In group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: pentazocine (Drug)
Group C
In group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.
干预措施: propofol (Drug)
结局指标
主要结局
Heart rate
时间窗: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Heart rate will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Blood pressure
时间窗: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Blood pressure will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
Pulse oxygen saturation
时间窗: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Pulse oxygen saturation will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate.
次要结局
- Dose of propofol or mixture of propofol and etomidate(from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min)
- Use of specific medications(from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour)
- Aldrete score(10 min after the opration)
- Satisfaction degree of the patient, the surgeon and the anesthetist(10 min before discharge from the hospital)
- Efficacy of anesthesia(from baseline to discharge from the hospital, expected to no more than 1 hour)
- Verbal rating scales of uterine contraction(from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour)