Carbetocin Versus Syntocinon for Prevention of Postpartum Hemorrhage in Cardiac Patients With Stenotic Valvular Heart Disease Undergoing Caesarean Section
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cardiac output
研究概览
简要总结
Postpartum hemorrhage (PPH) is the primary cause of nearly one quarter of all maternal deaths globally. Management of uterine tone after delivery involves giving a prophylactic uterotonic and the use of controlled cord traction to facilitate delivery of the placenta and minimize blood loss. Syntocinon and carbetocin are the most commonly used drugs ,During caesarean delivery of stenotic valvular disease patient, the anesthesiologist have an important question: what is the best drug used for prevention of PPH with minimal hemodynamic effect regarding Systemic vascular resistance (SVR), Cardiac out put (COP),Heart rate ( HR), blood pressure? As uterotonic drugs may cause severe hypotension, decrease in SVR and COP that may not be tolerated by these patients .this thesis aims to compare between syntocinon and carbetocin regarding their effect on cardiac output and systemic vascular resistance using cardiometry in cardiac patients with stenotic lesions during caesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant female single tone >38 weeks
- •Age :18-45 years old.
- •patient with ASA III
- •Cardiac patients ( mild and moderate mitral stenosis-aortic stenosis valve disease )
排除标准
- •Other cardiac conditions (valve regurge, cardiomyopathy, heart failure,severe mitral stenosis, severe aortic stenosis, severe pulmonary hypertension)
- •Pregnancy hypertensive disorders (eclampsia,preeclampsia)
- •Abnormal placental attachment (accrete,percreta,increta)
- •Patients with bleeding disorders
- •patient with high risk of postpartum haemorrhage
研究组 & 干预措施
syntocinon group
in this group :5 mL syringe containing a bolus of 1 IU of oxytocin and infusion syringe which will be prepared with a 50 mL syringe containing 0.4 IU/mL of oxytocin and infusion rate of 7.5 IU/h will be administrated to the patient after delivery of the fetus shoulder, Additional bolus syringes will be prepared for use as rescue boluses if needed " which will be 5 ml syringe containing 3 IU of oxytocin
干预措施: Syntocinon (Drug)
carbetocin group
in this group :5 mL syringe containing a bolus of 100 mcg of carbetocin and infusion syringe " which will be prepared with a 50 mL syringe containing normal saline will be administrated for the patient after delivery of the fetus shoulder. Additional bolus syringes will be prepared for use as rescue boluses if needed which will be 5 ml syringe containing 100 mcg of carbetocin
干预措施: Carbetocin (Drug)
结局指标
主要结局
Cardiac output
时间窗: intraoperative
Average Cardiac output after study drug administration
次要结局
- systemic vascular resistance(intraoperative)
研究者
Sherin Refaat
Assistant professor of anesthiology
Cairo University