Randomised Study to Compare the Regain of Gastrointestinal Motility After General Anaesthesia Versus Spinal Anaesthesia in Caesarean Section.Kasr El Ainy,Egypt Experience
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time of first flatus
研究概览
简要总结
This study aims to compare the time to regain intestinal motility after general anesthesia versus spinal anesthesia for cesarean section.
A double blinded randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt, between July 20 and November 20, 2015. In the study hospital, the total number of deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.
详细描述
The The study protocol was approved by the Scientific Research Committee of the department. Pregnant women with indication for caesarean section were enrolled after providing informed consent. It included 450 patients who had caesarean section and were subdivided into two groups according to a randomization scale.On the day of the operation,each randomly received a closed opaque envelope for the selection of the procedure(spinal versus general).
Patients were classified into two groups:
Group A: General anaesthesia group Group B:Spinal anaesthesia group.
All patients are subjected to the following:
- Patients admitted from the outpatient clinic at Kasr El Ainy university Maternity Hospital.
- Explanation of the procedure to all women participating in the study.
- Informed written consent from every woman participating in this study.
- Full history taking:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients set for planned cesarean section under general or spinal anesthesia:
- •age from 18 to 37 years.
- •Full term(37-41 weeks).
- •Singleton pregnancy.
- •Hemoglobin level more than 11 gm/dl.
排除标准
- •Contraindication to regional anesthesia i.e(patient refusal,coagulopathy,significant hypovolemia,systemic or local sepsis,increased intracranial pressure,severe stenotic valvular heart disease,pre existing neurologic conditions and local anesthetic or fentanyl allergy.
- •High risk pregnancies as pre eclampsia,eclampsia,any medical disorder(DM,cardiac and thyroid diseases).
- •Previous intestinal surgery,previous C.S. and previous gynecological operations.
结局指标
主要结局
Time of first flatus
时间窗: 3 months
次要结局
- postoperative complications(2 months)
研究者
Mohamed El-Sharkawy
Lecturer of obstetrics and gynecology
Kasr El Aini Hospital