Prophylactic Intravenous Injection of Neostigmine Plus Atropine Versus Ketorolac on Post-dural Puncture Headache in Patients Undergoing Infraumbilical Surgeries: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- postdural puncture headache
研究概览
简要总结
Post-dural puncture headache (PDPH) or spinal (or post-spinal) headache is one of the most common side effects of spinal anesthesia, with an incidence of 6-36%. The incidence of this complication was reported to be 76-85% after accidental dural puncture in epidural anesthesia. It usually starts within several hours after spinal anesthesia, but sometimes it can be delayed for up to 2 weeks, which usually resolves within a few days
详细描述
The usual symptoms of PDPH other than headache are photophobia, neck stiffness, nausea and vomiting, diplopia, tinnitus, and dizziness. The headache is usually throbbing and severe, starting from the forehead and extending to the occiput, and is aggravated by standing or sitting. This is due to meningeal traction associated with cerebrospinal fluid (CSF) pressure reduction or dilation of cerebral arteries as an indirect effect of lowering CSF pressure as a result of CSF leakage from the punctured dura. Current treatments or preventive measures for PDPH other than bed rest and hydration include theophylline, sumatriptan, caffeine, etc. In resistant or severe cases, epidural blood patch (EBP) is a well-described technique used to provide relief of pain.
The co-administration of neostigmine and atropine is a common treatment for terminating the effects of non-depolarizing muscle relaxants in the setting of general anesthesia with minimal side
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI less than 35 kg/m2
- •Scheduled for infraumbilical surgeries
- •American Society of Anesthesiologists (ASA) physical status: I and II
排除标准
- •ASA physical status more than II.
- •History of allrgic response to local anaesthetics or any of the medications used in the study
- •Patients with cognitive impairment
- •Basal body temperature of more than 38°C or less than 36°C
- •BMI more than 35 kg/m2
研究组 & 干预措施
Group C
patients will receive placebo (normal saline)
干预措施: normal Saline (Drug)
Group N
patients will receive neostigmine (40 μg/kg) plus atropine (20 μg/kg)
干预措施: Neostigmine (Drug)
Group K
patients will receive ketorolac (0.5 mg/kg)
干预措施: Ketorolac (Drug)
结局指标
主要结局
postdural puncture headache
时间窗: 1 week
the incidence of occurrence of PDPH in patients undergoing infraumbilical surgeries under SA.
次要结局
未报告次要终点
研究者
Ghada Mohammed AboelFadl
Principal investigator
Assiut University