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

NCT07816848 | Completed

• 2 other identifiers: FEP-MG-UGIE-2026UH26030344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain

Keywords

Upper Gastrointestinal Endoscopy; Mucosal Biopsy; Magnesium Sulfate; Modified Esophageal Symptoms Questionnaire; Interleukin-6; Serum Calcium; Perioperative Analgesia; Post-Endoscopic Esophageal Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• 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

Study Arms (2)

Intravenous Magnesium Sulfate

EXPERIMENTAL

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.

Drug: Magnesium sulfate (MgSO4) infusion

0.9% Sodium Chloride

PLACEBO COMPARATOR

Participants received 0.9% normal saline placebo at an identical volume and infusion rate to the magnesium sulfate intervention.

Drug: 0.9 % sodium chloride

Interventions

Magnesium sulfate (MgSO4) infusion DRUG

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.

Also known as: MgSO4

Intravenous Magnesium Sulfate

0.9 % sodium chloride DRUG

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.

Also known as: Normal Saline

0.9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dr. Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, 90221, Indonesia

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Magnesium Sulfate; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Fiqih E Putra, S.Ked

  Faculty of Medicine, Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Anesthesiology, Intensive Care and Pain Management

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: March 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 15, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)