Comparitive study of fixed dose versus height adjusted dose of heavy bupivacaine in spinal anaesthesia for elective caesarean section
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2.Time to reach T8 sensory level
研究概览
简要总结
This study is randomized double blind parallel group trial comparing height based optimization (0.06mg/cm) Vs fixed 11 mg/2.2 ml)of heavy bupivacaine in spinal anaesthesia for patients posted for elective caesarean section in RIMS Ranchi in INDIA.THE Primary objective is to study incidence of hypotension and block characteristics.The secondary objective is to study the total dose of mephentermine consumption and side effects.Inclusion criteria included singleton, uncomplicated pregnancy of ASA physical status II.The hypothesis of the study is height based optimization of dose of bupivacaine will minimize hypotension and would provide adequate anaesthesia for caesarean section.Various studies such as Huang B,Huang Q found that height adjusted dose of spinal anaesthesia in parturient provides sufficient anaesthesia and low incidence of maternal hypotension and that prophylactic fliluid preloading and vasopressor are unnecessary.
Sabale P et al found that height based dose of spinal anaesthesia decreases the chance of hypotension,need of vasopressor with better hemodynamic stability and decreased incidence of side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient consent 2.Age group.
- •21years to 40years scheduled for elective caesarean section 3.singleton pregnancy 4.Weight -40 to 80 kg 5.Height- 140cm-170cm 5.ASA II.
排除标准
- •1.patient refusal 2.patient with contraindication to spinal anaesthesia 3.patient with cardiovascular disease,pre eclampsia,eclampsia and systolic BP<90 mmHg 4.Women with fetal abnormalities 5.women with placental abnormalities.
结局指标
主要结局
2.Time to reach T8 sensory level
时间窗: 24 hrs
4.Time taken for 2 segment sensory regression
时间窗: 24 hrs
5.Time to achieve modified bromage score 3
时间窗: 24 hrs
1.Incidence of maternal hypotension
时间窗: 24 hrs
3.Maximum sensory level achieved and time to reach the same
时间窗: 24 hrs
次要结局
- 1.Total dose of mephentermine consumption(2.APGAR score at 1 and 5 min)