Double blind randomised clinical trial to determine the effective bolus dose of norepinephrine in preventing spinal hypotension during caesarean delivery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of spinal hypotension, defined as systolic blood pressure decrease to 80% of baseline between initiation of intrathecal injection and delivery.
研究概览
简要总结
This randomized double-blind clinical trial aims to determine the effective bolus dose of norepinephrine to prevent spinal hypotension during cesarean delivery, a common complication of spinal anesthesia. Norepinephrine, with its strong alpha agonist and mild beta agonist activity, offers better hemodynamic stability compared to ephedrine and phenylephrine. A total of 130 term parturients aged 20–45 years (ASA II) undergoing elective or emergency cesarean section at KIMS, Hubli, will be randomized into two groups to receive either 0.05 mcg per kg or 0.10 mcg per kg norepinephrine bolus followed by a fixed-rate infusion. Maternal blood pressure, heart rate, need for rescue drugs, and adverse effects such as bradycardia, nausea, and vomiting will be recorded. The primary outcome is the incidence of spinal hypotension, and secondary outcomes include severity of hypotension, hypertension episodes, rescue drug usage, and hemodynamic changes. Data will be analyzed using SPSS with significance at p less than 0.05.
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
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Parturients undergoing elective/emergency caesarean birth under spinal anaesthesia.
- •.Full term singleton gestation.
- •.American Society of Anaesthesiology Physical Status score of II.
排除标准
- •History of hypertension or cardiovascular disease.
- •Severely impaired liver or kidney function.
- •Coagulation abnormalities.
- •Patients on anti platelet and anticoagulant agents.
- •Fetal abnormality.
- •History of epilepsy.
- •Patients who do not give consent.
结局指标
主要结局
Incidence of spinal hypotension, defined as systolic blood pressure decrease to 80% of baseline between initiation of intrathecal injection and delivery.
时间窗: From initiation of intrathecal bupivacaine injection until delivery of baby
次要结局
- Frequency of hypertension & severe spinal hypotension(Rescue drug administered from the time of subarachnoid block to the delivery)
研究者
Pooja H S
KMCRI Hubli
