Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to first voiding after treatment
研究概览
简要总结
The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia
详细描述
Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume > 600 ml by ultrasound), urinary catheterization will be done.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women undergoing elective cesarean deliver under spinal anesthesia.
排除标准
- •The age of the patient is more than 35 years of less than 20 years.
- •The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm.
- •Multiple gestation.
- •The patient is in active labor.
- •Vaginal bleeding, placenta previa or abruption of the placenta.
- •Presence of fetal distress.
- •Urinary symptoms.
- •Medical disorders co-existing with or complicating pregnancy.
- •Contraindications for or history of adverse reaction of Neostigmine.
- •Contraindication for spinal anesthesia.
- •Refusal of the patient to receive spinal anesthesia.
- •Intraoperative significant hemorrhage.
- •Duration of the operation is more than one hour.
- •Occurrence of postoperative complications as eclampsia.
研究组 & 干预措施
Neostigmine group
After cesarean delivery, women will receive 0.5 mg IM neostigmine
干预措施: Neostigmine (Drug)
Placebo group
After cesarean delivery, women will receive IM NaCl 0.9% as a placebo
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Time to first voiding after treatment
时间窗: Until 12 hours postoperatively
Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding
Time to first voiding after catheter removal
时间窗: Until 12 hours postoperatively
Time interval between catheter removal and occurrence of first voiding
次要结局
未报告次要终点