Procedural Pain
Conditions
Keywords
Upper Gastrointestinal Endoscopy, Mucosal Biopsy, Magnesium Sulfate, Modified Esophageal Symptoms Questionnaire, Interleukin-6, Serum Calcium, Perioperative Analgesia, Post-Endoscopic Esophageal Symptoms
Brief summary
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.
Detailed description
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.
Interventions
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% normal saline was administered intravenously using an identical volume and infusion rate to the magnesium sulfate intervention and was delivered using a syringe pump.
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants were randomly assigned in a 1:1 ratio to receive either intravenous magnesium sulfate or 0.9% normal saline placebo in two parallel treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Interleukin-6 Concentration | 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). |
| Change in Total Serum Calcium Concentration | 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. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORFiqih E Putra, S.Ked
Faculty of Medicine, Hasanuddin University
Outcome results
None listed