Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache: a Randomized Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.
研究概览
简要总结
Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-50 years old.
- •both sex.
- •ASA physical status I and II.
- •70-90 kg body weight.
- •height 160-180 cm.
- •Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.
排除标准
- •Patients with impaired kidney or liver functions.
- •history of cardiac or central nervous system disease.
- •uncontrolled medical disease (diabetes mellitus and hypertension)
- •history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
- •allergy to the used medications
- •patient's refusal
- •duration of surgery more than 120 minutes.
研究组 & 干预措施
Group (I) (N=25)
Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).
干预措施: hydrocortisone 100mg. (Drug)
Group (II) (N=25)
group (II), received mannitol 20% intravenous fluid (100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis for 48 hours) (Manufactured by Allmed Middle East, Egypt).
干预措施: mannitol 20% intravenous fluid (Drug)
结局指标
主要结局
Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.
时间窗: within 48 hours after starting of treatment
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Dr.Ibrahim Mamdouh Esmat
Ain Shams University