Comparison of Prophylactic Intravenous Acetaminophen With Aminophylline and Aminophylline With Dexamethasone for Post Dural Puncture Headache Prevention in Surgical Patients With History of PDPH
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH.
研究概览
简要总结
It is hypothesized that there is a difference between intravenously administered aminophylline with intravenous acetaminophen and intravenously administered aminophylline with dexamethasone for prevention of and reducing severity of PDPH.
详细描述
Aim of the study is to compare intravenous aminophylline plus dexamethasone with intravenous acetaminophen and intravenous aminophylline on post dural puncture headache prevention after spinal anesthesia in terms of incidence of PDPH, VAS scores between the groups. . Patients will be randomly divided into two equal groups. (Group A1) who will receive aminophylline with acetaminophen infusion slowly and (Group A2) who will receive aminophylline with dexamethasone Infusion. Study variables will be noted in predesigned study proforma. Data will be entered on software SPSS version 26.0 and will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 18-40 years.
- •Elective surgery under spinal anesthesia
- •Those patients having history of PDPH
- •BMI≤ 35kg/m2
- •American Society of Anesthesiologist (ASA) Physical Status I and II
排除标准
- •History of known allergy or hypersensitivity against study drug
- •Emergency surgery
- •Obstetric patient
- •Failed spinal
- •Multiple attempts of spinal
- •Contraindication to Spinal Anesthesia
- •Chronic disease patients already taking opioids or NSAIDs
- •History of migraine or other headaches
- •Partially effective spinal anesthesia
- •Abnormal liver or kidney function, cardiovascular system diseases, respiratory system diseases and diseases of the nervous system
- •Intraoperative blood loss >1000ml
- •Intraoperative hemodynamic instability
研究组 & 干预措施
Acetaminophen+Aminophylline (n=25)
This group will receive Inj. Aminophylline 100mg as slow IV. Infusion over 30 minutes followed by inj. Acetaminophen 1000mg in 100 ml Normal saline solution as slow infusion.
干预措施: Inj Aminophylline 100mg with Inj Acetaminophen 1000mg in 100ml Normal Saline (Drug)
Aminophylline+Dexamethasone (n=25)
This group will receive Inj. Aminophylline 100mg as slow IV infusion over 30minutes followed by 0.1mg/kg dexamethasone in 100ml Normal saline IV infusion.
干预措施: Inj Aminophylline 100mg , with 0.1mg/kg Dexamethasone in 100ml Normal Saline (Drug)
结局指标
主要结局
The primary outcome of the study is to see effectiveness of intravenous aminophylline in combination with dexamethasone and acetaminophen in terms of reducing incidence of PDPH in surgical patients with history of PDPH.
时间窗: 3 days
Reduced Incidence of PDPH
次要结局
- Prophylactic administration of Aminophylline with Acetaminophen and Aminophylline with Dexamethasone on post-dural puncture headache prevention after spinal anesthesia in terms of reduced severity of PDPH by VAS scores.(3 days)