A comparative evaluation of pre-loading and co-loading of crystalloids in determining the incidence of hypotension in parturients undergoing caesarean section under spinal anaesthesia - a prospective randomized comparative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To study and compare the systolic blood pressure(SBP) in parturients undergoing caesarean section under spinal anaesthesia with pre-loading or co-loading of crystalloid.
研究概览
简要总结
This prospective, randomized clinical comparative study will be conducted after obtaining approval from Scientific Research Committee and the Institutional Ethics Committee and written informed consent of patients. Seventy patients fulfilling the inclusion criteria, scheduled for surgery under spinal anaesthesia with pre-loading or co-loading of crystalloid will be enrolled in the study. Patients will be allocated to one of the two study groups after randomization. In Group A, pre-loading will be done and in Group B ,co-loading will be done with crystalloid. The two will be compared with respect to incidence of hypotension between the two groups, assessment of vasopressor requirement and complications if any
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients with singleton pregnancy undergoing caeserean delivery under spinal anaesthesia with ASA physical status II and Height more than 150cms.
排除标准
- •History of allergy to local anaesthetic agent, parturients with cardiovascular, respiratory or hepato-renal disease and coagulopathy , thrombocytopenia or any contraindication to spinal anaesthesia.
结局指标
主要结局
To study and compare the systolic blood pressure(SBP) in parturients undergoing caesarean section under spinal anaesthesia with pre-loading or co-loading of crystalloid.
时间窗: Baseline haemodynamic parameters to be observed before initiation of spinal anaesthesia and haemodynamic parameters to be observed at 0,3,6,9,12,15 minutes till the end of surgery.
次要结局
- To assess & compare the Mean Arterial Pressure (MAP), Diastolic Blood Pressure (DBP), Heart Rate (HR) in parturients undergoing caesarean delivery under spinal anaesthesia with pre-loading or co-loading of crystalloid, with evaluation & comparison of vasopressor requirement & to assess any comlications, if any.(Baseline haemodynamic parameters to be observed before initiation of spinal anaesthesia & haemodynamic parameters to be observed at 0,3,6,9,12,15 minutes till the end of surgery.)
研究者
Dr Vedanshi Singh
Deen Dayal Upadhyay Hospital