A Prospective, Randomized, Double-blind, Placebo-controlled Trial of the Effects of Magnesium Sulfate on Postoperative Esophageal Spasm-associated Pain Following Peroral Endoscopic Myotomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Esophageal Symptoms Questionnaire Score (ESQ)
研究概览
简要总结
Postoperative pain after peroral endoscopic myotomy occurs due to involuntary esophageal smooth muscle spasms. Magnesium has antispasmodic properties as a smooth muscle relaxant. This study hypothesizes that among patients having peroral endoscopic myotomy, magnesium will decrease postoperative esophgeal pain as measured by the esophageal symptoms questionnaire, while decreasing perioperative opioid requirements.
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
- Double (Participant, Care Provider)
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
- •Planned peroral endoscopic myotomy procedure
排除标准
- •cannot give consent
- •patients who are clinically unstable and/or require urgent/emergent intervention
- •previous esophageal myotomy
- •preexisting hypermagnesemia
- •end-stage renal disease
- •neuromuscular disease, including but not limited to Guillain-Barre syndrome, myasthenia gravis, congenital myopathy, and muscular dystrophy
- •preexisting heart failure
- •severe ventricular systolic dysfunction (left or right ventricle)
研究组 & 干预措施
Magnesium sulfate 50 mg/kg bolus + 25 mg/kg/hr infusion
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
干预措施: Magnesium sulfate (Drug)
Normal saline 0.9% 50 mg/kg bolus + 25 mg/kg/hr infusion
Bolus to be administered at start of mucosal incision, followed by infusion. Infusion to be terminated at extubation.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Esophageal Symptoms Questionnaire Score (ESQ)
时间窗: 0 hours postoperatively
ESQ score is a validated survey score based on questions evaluating esophageal dysphagia, globus, and reflux. Participants answer 11 questions, each rated on a scale of 1 (Not severe) to 7 (Very severe). Scores were summed for an overall score (range 11 to 77, higher scores indicate more severe dysphagia).
次要结局
- Esophageal Symptoms Questionnaire Score (ESQ)(24 hours postoperatively)
- Postoperative Opioid Consumption(From extubation to 24 hours after extubation)
- Postoperative Day 1 Opioid Consumption(From 24 hours after extubation to 48 hours after extubation)
- Average Visual Acuity Score Pain Score in Postanesthesia Care Unit(From extubation to discharge from postanesthesia care unit (up to 4 hours))
研究者
Richard K. Kim
Clinical Assistant Professor
Stanford University