comparison of intermittent boluses of nor-epinephrine and phenylephrine for prevention of subarachnoid block induced hypotension in cesarean section
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparative success of intermittent boluses of nor-epinephrine and phenylephrine to maintain systolic blood pressure (SBP) at 90-100% of baseline, from induction of spinal anesthesia to delivery of fetus.
研究概览
简要总结
A prospective ,double blind randomised study will be conducted on 200 ASA-II parturients undergoing cesarean section (CS) under subarachnoid block (SAB),who will be randomised to 2 groups A and B to receive intermittent bolus doses of nor-epinephrine or phenylephrine every time the systolic blood pressure (SBP) falls by 10 % from the baseline value. Our primary outcome is to elucidate comparative efficacy of intermittent boluses of study drugs to maintain systolic blood pressure (SBP) at 90-100% of baseline. Incidence of intraoperative nausea/vomiting [IONV], hypertension (SBP>120% of baseline), bradycardia (<50bpm), fetal APGAR score at 1 min and 5 min and total amount of vasopressor consumption will be recorded. Data thus collected will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •American society of Anesthesiologists (ASA) physical status II undergoing lower segment cesarean section (LSCS) under subarachnoid block (SAB).
- •Primigravida.
- •Healthy singleton pregnancy.
- •Age more than 18 years.
- •Weight 50-100 kg.
- •Height 150-180 cm.
排除标准
- •Onset of labour.
- •Known fetal abnormality.
- •Severe cardiovascular or cerebrovascular disease or renal impairment.
- •Known allergy to any study medication.
- •Patients taking monoamine oxidase or tricyclic antidepressants.
- •Presence of mesenteric or peripheral vascular thrombosis.
结局指标
主要结局
Comparative success of intermittent boluses of nor-epinephrine and phenylephrine to maintain systolic blood pressure (SBP) at 90-100% of baseline, from induction of spinal anesthesia to delivery of fetus.
时间窗: From induction of spinal anesthesia to delivery of fetus
次要结局
- .Total amount of(boluses of Nor-)