Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Uterine tonus
研究概览
简要总结
To compare the effects of oxytocin and carbetocin, used as uterotonics in elective caesarean section surgeries, in terms of intraoperative hemodynamic changes.
详细描述
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective caesarean section surgeries , aged 18-40 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each.
All cases will receive routine preparation for general anesthesia. All patients placed on the operating room will receive two large-bore vascular access. For anesthesia induction 2 mg/kg propofol and 0.5 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 2 MAC sevoflurane.Demographic data of the patients (age, height, weight), ASA score and surgical time will be recorded. During the operation, hemodynamic parameters will be recorded just before the drugs are given and at the 1st, 5th, 10th, 15th, 20th, 25th and 30th minutes after the drug is given. In addition, intraoperative blood loss and the need for additional uterotonics throughout the surgery will be recorded. All data will be recorded and statistical analysis will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for caesarean sections
- •Between 18-40 years
- •ASA I-II group
- •Those who will undergo general anesthesia
- •Those between 35-40 weeks of pregnancy
- •1st and 2nd caesarean sections
排除标准
- •Those who prefer spinal or epidural anesthesia
- •Those who are outside the age range of 18-40
- •Those who are ASA III and above
- •Those with HT, DM, cardiac and respiratory diseases
- •Preeclampsia, eclampsia, HELLP
- •Those with a history of drug use that affects the cardiovascular system
- •Placenta Previa, Placenta Acreta, Placenta Acreta
结局指标
主要结局
Uterine tonus
时间窗: For 30 minutes after carbetocin administration.
The effect of carbetocin on uterine tone will be evaluated by the surgical team using a numerical scoring scale between 0-10. A score of 0 will indicate atony, and a score of 10 will indicate full contraction.
Additional uterotonic drug requirement
时间窗: For 30 minutes after carbetocin administration.
If the uterine tone is 7 or below, the surgical team will perform uterine massage, and in patients who do not see a sufficient increase in uterine tone, an additional uterotonic, 0.2 mg methylergonavine (Methyl ampoule 0.2 mg/ml) will be administered IM by the anesthesia team and recorded.
次要结局
- Intraoperative bleeding(from drug administration to the end of surgery.)
- Mean Blood Pressure(Intraoperatively every 5 minutes)
- Heart Rate(Intraoperatively every 5 minutes)
研究者
Nurettin KURT
Assistant Professor
Yuzuncu Yıl University