Intravenous Magnesium Sulfate for Post-Endoscopic Symptoms After Upper Gastrointestinal Endoscopy With Biopsy

Hasanuddin University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Interventions

Magnesium sulfate (MgSO4) infusionDRUG

Magnesium sulfate was administered intravenously at a loading dose of 50 mg/kg body weight over 15 minutes before induction of anesthesia, followed by a continuous intravenous infusion of 25 mg/kg/hour until completion of the UGIE procedure. Infusions were administered using a syringe pump.

0.9 % sodium chlorideDRUG

0.9% normal saline was administered intravenously using an identical volume and infusion rate to the magnesium sulfate intervention and was delivered using a syringe pump.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire

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.

Time frame: 1, 4, 24, and 48 hours after completion of Upper Gastrointestinal Endocopy (UGIE) with biopsy

Secondary Outcomes

Change in Serum Interleukin-6 Concentration

Change in serum interleukin-6 (IL-6) concentration was defined as the serum IL-6 concentration measured 1 hour after completion of UGIE minus the baseline concentration measured immediately before the study intervention and UGIE. IL-6 concentrations were measured in pg/mL using the Human IL-6 ELISA Kit, BT LAB® (Cat. No. E0090Hu).

Time frame: Baseline to 1 hour after completion of UGIE

Change in Total Serum Calcium Concentration

Change in total serum calcium concentration was defined as the total serum calcium concentration measured 1 hour after completion of UGIE minus the baseline concentration measured immediately before the study intervention and UGIE. Total serum calcium was measured using a colorimetric/spectrophotometric assay and reported in mg/dL.