Dr. Wahidin Sudirohusodo Hospital
Makassar, South Sulawesi, 90221, Indonesia
NCT Number: NCT07816848
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Makassar, South Sulawesi, 90221, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: MgSO4
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.
Other names: Normal Saline
Time frame: 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.
Time frame: Baseline to 1 hour after completion of UGIE
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 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.
Hasanuddin University
Other
Intravenous Magnesium Sulfate Reduces Post-Endoscopic Symptom Severity and Attenuates IL-6 Response Following Upper Gastrointestinal Endoscopy With Biopsy: A Randomized Placebo-Controlled Trial
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