Comparative study of Phenylephrine infusion and Norepinephrine infusion for prevention and treatment of spinal anaesthesia induced hypotension in elective and emergency cesarean deliveries.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1)Systolic blood pressure
研究概览
简要总结
Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anaesthesia for cesarean section. Severe hypotension in obstetrics patient will lead to decreased oragn perfusion, dyspnoea, nausea, vomiting in the mother and depressed APGAR score and fetal acidosis in the fetus. The measures in the form of positioning to prevent aortocaval compression and pre or co loading of crystelloids have not been proven to completely prevent post spinal hypotension. Vasopressors like ephedrine and phenylephrine are being used routinely nowadays to prevent or treat post spinal hypotension in addition to above mentioned measures. Both vasopressors have their own pros and cons and various studies have been done to check their efficacy and safety profile. Phenylephrine is the preffered agent as per the literatures available. Norepinephrine has been found to have better profile as a vasopressor theoritically. There are on;y few studies to support this. So we planned to do comparative study of effects of npth drugs by intravenous infusion on feto-metarnal outcomes ny preventing and treating post spinal hypotension in cesarean sections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •All pregnant patients undergoing elective and emergency cesarian who have been given consent for American Society of Anesthesiologists grade 2 and 3 and do not have contraindication to any of the drugs to be studied.
排除标准
- •Pregnant females with gestational age of less than 36 weeks 2)Known co-morbidities such as severe pregnancy induced hypertension, Diabetes Mellitus, cardiac diseases, epilepsy, eclampsia 3)Patient refusing for spinal anaesthesia 4)contraindication for spinal anaesthesia.
结局指标
主要结局
1)Systolic blood pressure
时间窗: different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes
3)Mean arterial pressure
时间窗: different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes
4)Heart rate
时间窗: different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes
2)Diastolic blood pressure
时间窗: different hemodynaemic and vital parameters at different point of time after spinal anaesthesia | 1)baseline | 2)at 2 minutes | 3)at 4 minutes | 4)at 6 minutes | 5)at 8 minutes | 6)at 10 minutes | 7)at 15 minutes | 8)at 20 minutes | 10)at 30 minutes | 11)at 45 minutes | 12)at 60 minutes
次要结局
- occurance of materal nausea and vomiting(at any given time)
- APGAR score(at 1 minute and 5 minutes)