Intravenous Magnesium Sulfate Reduces Post-Endoscopic Symptom Severity and Attenuates IL-6 Response Following Upper Gastrointestinal Endoscopy With Biopsy: A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire
研究概览
简要总结
This randomized placebo-controlled clinical trial evaluated whether intravenous magnesium sulfate reduces esophageal symptoms after upper gastrointestinal endoscopy (UGIE) with biopsy in adult patients. Participants were randomly assigned in a 1:1 ratio to receive either intravenous magnesium sulfate or 0.9% sodium chloride placebo. Post-endoscopic esophageal symptoms were assessed using the Modified Esophageal Symptoms Questionnaire (M-ESQ) at 1, 4, 24, and 48 hours after the procedure. Serum interleukin-6 (IL-6) and total calcium concentrations were measured before the procedure and 1 hour after the procedure to evaluate inflammatory and pharmacodynamic responses to magnesium sulfate.
详细描述
Post-endoscopic esophageal symptoms following upper gastrointestinal endoscopy (UGIE) with mucosal biopsy may arise from mechanical mucosal injury, acute inflammatory activation, and nociceptive sensitization. Magnesium sulfate may modulate these responses through antagonism of N-methyl-D-aspartate (NMDA) receptor activity, regulation of calcium influx, and attenuation of pro-inflammatory signaling.
Eligible participants were assigned in a 1:1 ratio using computer-generated block randomization with variable block sizes of 4 and 6. Allocation concealment was maintained using sequentially numbered opaque sealed envelopes. Participants, endoscopists, postoperative outcome assessors, laboratory analysts, and statisticians were blinded to treatment allocation. The attending anesthesiologist was aware of group assignment for patient safety but was not involved in postoperative outcome assessment or statistical analysis. Perioperative anesthesia and monitoring were standardized for both treatment groups.
In addition to evaluating post-endoscopic symptom severity and peri-procedural changes in serum interleukin-6 (IL-6) and total serum calcium, an exploratory analysis examined the association between the change in serum IL-6 from baseline to 1 hour after the procedure and the Modifies Esophageal Symptomps Questionnaire score measured at the corresponding 1-hour postprocedural time point. This association was evaluated using Spearman rank correlation in the overall study population and separately within each treatment group.
Participants were monitored for magnesium-related adverse effects, including hypotension, bradycardia, respiratory depression, muscle weakness, and altered mental status. Intravenous calcium gluconate was available as rescue treatment in the event of clinically suspected magnesium toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors were blinded to treatment allocation. Endoscopists, laboratory analysts, and statisticians were also blinded. The attending anesthesiologist was aware of treatment allocation for patient safety but was not involved in postoperative outcome assessment or statistical analysis. Study solutions were prepared by designated research personnel not involved in outcome assessment.
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
- •Adults aged 18 years or older.
- •Scheduled to undergo elective upper gastrointestinal endoscopy (UGIE) with mucosal biopsy under general anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Able to provide written informed consent.
排除标准
- •History of hypersensitivity to magnesium sulfate.
- •Severe renal dysfunction.
- •Second- or third-degree atrioventricular block.
- •Neuromuscular disease.
- •Chronic opioid therapy.
- •Pregnancy or lactation.
- •Any condition that could interfere with completion of postoperative assessments.
研究组 & 干预措施
Intravenous Magnesium Sulfate
Participants received intravenous magnesium sulfate at a loading dose of 50 mg/kg over 15 minutes before induction of anesthesia, followed by a continuous infusion of 25 mg/kg/hour until completion of the upper gastrointestinal endoscopy procedure.
干预措施: Magnesium sulfate (MgSO4) infusion (Drug)
0.9% Sodium Chloride
Participants received 0.9% normal saline placebo at an identical volume and infusion rate to the magnesium sulfate intervention.
干预措施: 0.9 % sodium chloride (Drug)
结局指标
主要结局
Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire
时间窗: 1, 4, 24, and 48 hours after completion of UGIE with biopsy
Post-endoscopic esophageal symptom severity was assessed using the Modified Esophageal Symptoms Questionnaire (M-ESQ), a patient-reported instrument evaluating esophageal symptoms following upper gastrointestinal endoscopy. Higher M-ESQ scores indicate greater post-endoscopic esophageal symptom severity. Assessments were performed at 1, 4, 24, and 48 hours after completion of the procedure.
Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire
时间窗: 1, 4, 24, and 48 hours after completion of Upper Gastrointestinal Endocopy (UGIE) with biopsy
The Modified Esophageal Symptoms Questionnaire (M-ESQ) is an 11-item patient-reported questionnaire assessing the severity of esophageal symptoms. Each item is scored from 1 (not severe) to 7 (very severe). Item scores are summed to produce a total score ranging from 11 to 77. Higher total scores indicate more severe esophageal symptoms and therefore a worse outcome.
次要结局
- Change in Serum Interleukin-6 Concentration(Baseline to 1 hour after completion of UGIE)
- Change in Total Serum Calcium Concentration(Baseline to 1 hour after completion of UGIE)
研究者
Fiqih Eka Putra
Resident in Anesthesiology, Intensive Care and Pain Management
Hasanuddin University
