Randomised controlled trial to study comparison between prophylactic bolus doses of norepinephrine and mephenteramine on hypotension after spinal anesthesia for cesarean section.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of incidence of hypotension which MAP less than 80% of baseline and incidence of bradycardia which is HR less than 60per minute among Group A and Group B
研究概览
简要总结
The aim of the study is to compare the equipotent doses of inj norepinephrine 8 micrograms and mephenteramine 6 mg for the prophylaxis of hypotension in LSCS after spinal Anesthesia. The subject and the anesthetist giving the drug will be blinded to the drug which will be given. Pregnant females aged between 18 to 45 years with single pregnancy without any comorbidity will be taken into study only after their consent. Patients with allergy to study drugs, multiple pregnancy,having any contraindication to spinal Anesthesia will be excluded from the study. Patient will be taken on the table after checking vitals spinal will be given to the patient and just after making the patient supine bolus dose of the drug will be given and NIBP and HR will be measured at 0,2,4,6,8,10,12,14 mins.
Other complains like nausea ,vomiting, headache will also be checked during the duration of LSCS
Patient will be monitored postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton, uncomplicated pregnancy undergoing LSCS under Spinal anesthesia.
排除标准
- •1 Pre eclampsia.
- •2 Multiple preganancy 3 Patients with operated spine.
- •ASA grade 3 or greater
- •Known allergy to study drug
- •Those who required respinal because of the failure of the ist one.
结局指标
主要结局
Comparison of incidence of hypotension which MAP less than 80% of baseline and incidence of bradycardia which is HR less than 60per minute among Group A and Group B
时间窗: After spinal Anesthesia at 0 mins and after every 2 mins till 14 mins
次要结局
- Comparison of effects of drugs on cord blood ph, and incidence of maternal nausea and vomiting ,headache among group A and B(During the duration of LSCS)
研究者
Harivart kaushik
Northern railway central hospital