To compare bolus doses of nor epinephrine and phenylephrine for treatment of maternal hypotension undergoing emergency lower segment cesarean section under subarachnoid block : A Randomized Clinical Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- 1.Haemodynamic Changes:
研究概览
简要总结
This study will be conducted in a prospective, randomized, double blinded and comparative manner in the Department of Anaesthesiology and Critical Care, Maharaja Agarsen Medical college, Agroha.The primary objective of the study will be to determine whether nor epinephrine is more effective compared to phenylephrine for treatment of maternal hypotension undergoing emergency lower segment cesarean section under subarachnoid block.The secondary objectives will be to determine effect of nor epinephrine and phenylephrine bolus on maternal heart rate and on fetal outcome by assessing APGAR score and investigating fetal acidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Those parturients who will develop hypotension after subarachnoid block, with systolic blood pressure being <20% of the baseline value will be included in the study.
排除标准
- •Parturients with:- 1.Fetal Abnormality.
- •2.Preexisting or Pregnancy Induced Hypertension.
- •3.Known Cardiovascular or Cerebrovascular Disease.
- •4.Thrombocytopenia.
- •5.Coagulopathy or any medical contraindication to spinal anesthesia.
- •6.Weight <50 kg or >100kg.
- •7.Height <140 cm or >180 cm.
- •8.Parturient using monoamine oxidase inhibitors or tricyclic anti-depressants.
- •9.Parturient allergic to study drug.
- •10.Refusal of informed consent.
结局指标
主要结局
1.Haemodynamic Changes:
时间窗: From administration of sub arachnoid block to end of surgery.
2.No. of boluses of vasopressor agents given intraoperatively will be noted.
时间窗: From administration of sub arachnoid block to end of surgery.
Blood pressure & HR will be monitored every 2 mins till 10 min, & thereafter every 5 min till the end of surgery.
时间窗: From administration of sub arachnoid block to end of surgery.
Incidence of hypotension, bradycardia, tachycardia, hypertension will be noted.
时间窗: From administration of sub arachnoid block to end of surgery.
次要结局
- 1.Fetal Outcome:(A paediatrician who will not be aware of the vasopressor used will note:)