Comparative efficacy of prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone on the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- To evaluate and compare the incidence of spinal anaesthesia mediated hypotension in parturients receiving prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone
研究概览
简要总结
Study Title: Comparative efficacy of prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone on the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean
section
Study Type: Double blind randomised controlled study
Objective: To compare efficacy of prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone on the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section.
Participants: Pregnant women of age 18 to 35 years, ASA PS II,singleton pregnancy with gestational age more than 37 weeks scheduled for elective cesarean delivery under spinal anaesthesia will be included in the study
Interventions:
Group A: Patients will receive intravenous dexamethasone 8mg in 10 ml saline over 1 minute in preoperative area 15 minutes prior to subarachnoid block
Group B: Patients will receive intravenous10 ml normal saline over 1 minute in pre operative area 15 minutes prior to subarachnoid block
Primary Outcome: To evaluate and compare the incidence of spinal anaesthesia mediated hypotension in parturients undergoing caesarean section in patients receiving intravenous dexamethasone and mephentermine versus mephentermine alone till 20 min after spinal anaesthesia
Secondary Outcomes:
To evaluate and compare
Haemodynamic parameters like heart rate and systolic blood pressure at
baseline, every 2 minutes till 20 minutes after spinal anaesthesia and then
at every 5 minute interval till the end of surgery.
Time to achieve T6 level of block
Total dose of mephentermine(mg) administered
Time to first rescue mephentermine bolus
Neonatal Apgar score at 1 minute and 5 minutes
Sample Size: 170 patients (85 per group) .
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women ASA PS 2, singleton pregnancy with gestational age more than 37 weeks scheduled for elective cesarean delivery under spinal anaesthesia.
排除标准
- •Patients with history suggestive of gestational or chronic diabetes and hypertensive disorders of pregnancy Recent intake of steroids BMI of more than 35 kg/m 2 Previous 2 caesarean section History of allergy to the study drugs Any contraindication to regional anaesthesia.
结局指标
主要结局
To evaluate and compare the incidence of spinal anaesthesia mediated hypotension in parturients receiving prophylactic intravenous dexamethasone and mephentermine versus mephentermine alone
时间窗: Till 20 minutes after spinal anaesthesia
次要结局
- Neonatal Apgar score(At 1 minute and 5 minutes)
- Haemodynamic parameters like heart rate and systolic blood pressure(At baseline, every 2 minutes and 20 minutes after spinal anaesthesia and then at every 5 minute)
- Time to achieve T6 level of block
- Total dose of mephentermine(mg) administered
- Time to first rescue mephentermine bolus
研究者
Dr Nisha Sangwan
Esic Medical College and Hospital