Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- visual analog scale score (VAS) ≤3 within 72 hour.
研究概览
简要总结
In our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (PDPH) after cesarean section.
详细描述
A written informed consent will be taken from the patients. The study will involve female adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed for study eligibility.
Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of postdural puncture headache (PDPH) after elective cesarean section under spinal anesthesia.
排除标准
- •Hypersensitivity of dexmedetomidine, neostigmine or atropine
- •Overactive thyroid gland
- •Myasthenia gravis
- •Closed angle glaucoma
- •High blood pressure and coronary artery disease.
- •withdrawal of consent
研究组 & 干预措施
Dexmedetomidine
Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
干预措施: Dexmedetomidine (Drug)
Neostigmine/atropine
Group N (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
干预措施: Neostigmine/atropine (Drug)
Saline placebo
Group S (patients will receive nebulization of saline placebo in 4 ml)twice daily for three days.
干预措施: Saline placebo (Other)
结局指标
主要结局
visual analog scale score (VAS) ≤3 within 72 hour.
时间窗: 3 days
change in visual analog scale score (VAS )for the assessment of the degree of headache (with 0 representing no headache and 10 cm representing the worst imaginable headache). a visual analog scale score ≤3 within 72 hour after intervention will be recorded.
次要结局
- Need for Epidural blood patch(Day 4)
- Occurence of neck stiffness(3 days)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University