Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Incidence of patients with post dural puncture headache
研究概览
简要总结
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturient ladies
- •Age ranges from 18 to 35 years old.
- •ASA II with elective caesarean section under sub-arachnoid block
排除标准
- •Refusal to participate
- •surgical complications necessitating a blood transfusion
- •Emergency caesarean section
- •the need for endotracheal intubation or vasopressors
- •any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events
研究组 & 干预措施
Control group
intravenous 50 mL of sterile saline 0.9% injection of 0.9% after umbilical cord clamping.
干预措施: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping. (Drug)
Neostgmine group
Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
干预措施: Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping. (Drug)
结局指标
主要结局
Incidence of patients with post dural puncture headache
时间窗: first 5 days post-partum
Number of patients develop post dural puncture headache
次要结局
- Analgesic request(24 hours after operation)
- Analgesc requirements(2 days after operation)
- Severity of post dural puncture headache(first 5 days post-partum)
- frequency of analgesic doses(5 days)
- incidence of complications related to the procedure(6 hours after procedure)
- onset and duration of post dural puncture headache(5 days post partum)
研究者
Mina Maher
Ass professor anesthesia and pain
Minia University