A Prospective Randomised double blinded study to compare the efficacy of prophylactic intravenous administration of Ondansetron 4 mg and granisetron 3mg for attenuation of spinal induced hypotension in parturients undergoing elective lower segment Caesarean section
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of hemodynamic parameters like systolic blood pressure and heart rate
研究概览
简要总结
This study is a prospective, randomised, double blinded, comparative trial, to compare the efficacy of prophylactic intravenous administration of two serotonin receptor antagonists i.e., ondansetron 4 mg and granisetron 3 mg in preventing spinal induced hypotension and bradycardia in parturients undergoing elective lower segment caesarean section. The study population will be allocated in two groups with 50 parturients in each group, and one of the study drug will be given 5 minutes before spinal anaesthesia and hemodynamic parameters such as blood pressure, heart rate and mean arterial pressure will b monitored intraoperatively.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients belonging to ASA grade 1 and 2 with more than 36 weeks gestation undergoing elective LSCS for a singleton pregnancy with Height 150.
排除标准
- •Patient refusal Parturients with spinal deformity Parturients with medical and obstretric complications like anemia, cardiac disease, gestational hypertension, gestational diabetes, shock, liver disorders, septicemia and hypertension.
- •Known hypersensitivity to local anaesthetics and study drugs.
- •Subjects having any absolute or relative contraindications for spinal anaesthesia like raised intracranial pressure, severe hypovolemia, bleeding diathesis and local infection.
- •Parturients with BMI more than 30 On drugs like selective serotonin reuptake inhibitors and migraine medications.
- •Intraoperative blood loss more than1 litre.
结局指标
主要结局
Comparison of hemodynamic parameters like systolic blood pressure and heart rate
时间窗: 2,4,6,8,10,15,20,25,30,35,40,50,60,70,80,90 minutes and till 3 hours postoperative period
次要结局
- To assess total requirement of intravenous ephedrine to treat hypotension and to assess intravenous atropine to treat bradycardia(to assess incidence of nausea vomiting and intra operative and post operative shivering)