NCT05806996已完成2 期
Magnesium and Bladder Spasms Following Ambulatory Urologic Procedures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Incidence of bladder spasm
研究概览
简要总结
This research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Be undergoing a bladder invasive procedure with or without planned urinary catheter on Mayo Clinic Gonda 7 Outpatient Procedure Center.
排除标准
- •Are unable to grant informed consent or comply with study procedure.
- •Allergy or known sensitivity to magnesium or Renacidin.
- •Expected or high risk of bladder extravasation.
- •Ongoing atrial fibrillation prior to surgery.
- •Are undergoing emergency surgery.
- •Are pregnant.
- •Known hypermagnesemia.
- •Patients with neuromuscular weakness (e.g., Myasthenia gravis) due to magnesium's muscle weakening effect.
- •Patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects.
- •Patients with renal insufficiency, glomerular filtration rate less than 30, since Magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium.
- •Patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.
研究组 & 干预措施
Placebo Group
Placebo Comparator
Subjects having urology surgery per standard of care will receive intravenous placebo during the surgery.
干预措施: Placebo (Drug)
Magnesium Group
Experimental
Subjects having urology surgery per standard of care will receive intravenous magnesium during the surgery.
干预措施: Magnesium (Drug)
结局指标
主要结局
Incidence of bladder spasm
时间窗: Post-operative, approximately 1 hour
Number of subjects to experience bladder spasms
次要结局
- Incidence of bladder spasm above moderate grade(Post-operative, approximately 4 hours)
- Treatment for bladder spasms(Post-operative, approximately 4 hours)
- Patient satisfaction(Post-operative, approximately 4 hours)
研究者
Gregory A Nuttall
Principal Investigator
Mayo Clinic
研究点 (3)
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