A prospective randomized study comparing the mean arterial pressure variations following administration of oxytocin and carbetocin in elective cesarean section under subarachnoid blockade
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to compare the mean arterial blood pressure variation following administration of oxytocin and carbetocin in lower segment cesarean section.
研究概览
简要总结
80 parturient undergoing elective caesarean section belonging to age group 20 to 30 years will be included in the study. Following the delivery of the fetus either oxytocin or Pitocin will be supplemented, and the hemodynamic parameters will be monitored. The study will be statistically analyzed using the statistical tests.
Purpose of the trial:
Oxytocin and Carbetocin is recommended as the standard treatment for postpartum hemorrhage. Any one of this uterotonic agents are used following the delivery of the baby. The added advantage of single bolus administration and less cardiovascular side effects are pronounced with more carbetocin when compared to oxytocin which favors the use of carbetocin in clinical practice. Many studies have been done considering the various dose formulations of oxytocin and carebetocni; however, there were not enough clinical information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Parturient acceptance 2.ASA status 2 and 3 3.Age between 20-30 yrs.
- •4.Parturient of term gestation undergoing elective lower segment cesarean section under spinal anesthesia.
排除标准
- •1.Absolute contraindications for spinal anesthesia 2.Combined spinal epidural anesthesia 3.Short stature <145cm and BMI > 40 4.Conditions associated with increased level of PPH risk (placenta previa, placentalabruption, multiple gestation).
结局指标
主要结局
The primary objective of this study is to compare the mean arterial blood pressure variation following administration of oxytocin and carbetocin in lower segment cesarean section.
时间窗: Baseline, 1,3,5,10 minutes and every 2nd minute following delivery of baby till 20 minutes
次要结局
- The secondary objective focusses on(1.Heart rate variations occurring between oxytocin and carbetocin)
研究者
Noorul Aashika A
PSG Institute of Medical Sciences and Research