Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
研究概览
简要总结
Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent Dural puncture during epidural anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The increased level of acetylcholine would produce cerebral vasoconstriction.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients American Society of anesthesiologists' physical status (ASA) II because of pregnancy.
- •Patients diagnosed with Postdural puncture headache following intrathecal spinal anesthesia for elective caesarean delivery.
排除标准
- •Patients with PDPH and a visual analog scale (VAS) score <
- •Patients with history of chronic headache, cluster headache, migraine, convulsions.
- •Patients with history of cerebrovascular accident, previous neurological diseases.
- •Patients with preeclampsia, eclampsia, coagulopathy.
- •Patients with severe bleeding (>20% of blood volume).
- •Patients undergoing treatment with vasopressors.
- •Patients with bronchial asthma.
- •Patients with arrhythmia, and any type of heart block.
研究组 & 干预措施
Pyridostigmine
Parturients with postoperative PDPH and a VAS score of ≥5 will receive either 60 mg oral Pyridostigmine every 6 hours.
干预措施: Pyridostigmine (Drug)
Placebo
Parturients with postoperative PDPH and a VAS score of ≥5 will receive placebo tablets similar in shape to pyridostigmine tablets every 6 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome is to determine the difference in VAS score between the Pyridostigmine group and the control group.
时间窗: 72 hours
Participants will be asked to report the severity of their headache after sitting upright for 15 minutes, using a 10-cm VAS( Visual analogue scale) after 72hours.
次要结局
- The need for an Epidural blood patch in the Pyridostigmine and control groups.(72 hours)
- Appearance of neck stiffness in the Pyridostigmine and control groups.(72 hours after the intervention)
- Appearance of Nausea and vomiting in the Pyridostigmine and control groups.(72 hours after the intervention)
研究者
riham fathy galal
Lecturer of Anesthesia intensive care and pain management
Ain Shams University