Procedural PainNCT07816848
Intravenous Magnesium Sulfate for Post-Endoscopic Symptoms After Upper Gastrointestinal Endoscopy With Biopsy
A study testing Magnesium sulfate (MgSO4) infusion and 0.9 % sodium chloride in people with Procedural Pain, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Magnesium sulfate (MgSO4) infusion and 0.9 % sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Wahidin Sudirohusodo Hospital
Makassar, South Sulawesi, 90221
About this study
Official title: Intravenous Magnesium Sulfate Reduces Post-Endoscopic Symptom Severity and Attenuates IL-6 Response Following Upper Gastrointestinal Endoscopy With Biopsy: A Randomized Placebo-Controlled Trial
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.
Read the 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.
- Conditions
- Procedural Pain
- Being tested
- Magnesium sulfate (MgSO4) infusion, 0.9 % sodium chloride
- Keywords
- Upper Gastrointestinal Endoscopy, Mucosal Biopsy, Magnesium Sulfate, Modified Esophageal Symptoms Questionnaire, Interleukin-6, Serum Calcium, Perioperative Analgesia, Post-Endoscopic Esophageal Symptoms
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate (MgSO4) infusionDrug
Also called MgSO4
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
Also called Normal Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 4, 24, and 48 hours after completion of Upper Gastrointestinal Endocopy (UGIE) with biopsy
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline to 1 hour after completion of UGIE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiqih Eka Putra, Hasanuddin University
- Investigators
- Fiqih E Putra, S.Ked, Principal investigator, Faculty of Medicine, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816848
- Sponsor's protocol ID
- FEP-MG-UGIE-2026
- Other IDs
- UH26030344
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Magnesium Sulfate Reduces Post-Endoscopic Symptom Severity and Attenuates IL-6 Response Following Upper Gastrointestinal Endoscopy With Biopsy: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07816848
- Acronym / sponsor ID
- FEP-MG-UGIE-2026
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous Magnesium Sulfate | Experimental | Drug: Magnesium sulfate (MgSO4) infusionParticipants 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. |
| 0.9% Sodium Chloride | Placebo comparator | Drug: 0.9 % sodium chlorideParticipants received 0.9% normal saline placebo at an identical volume and infusion rate to the magnesium sulfate intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- History of hypersensitivity to magnesium sulfate.
- Severe renal dysfunction.
- Second- or third-degree atrioventricular block.
- Neuromuscular disease.
- Chronic opioid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfate (MgSO4) infusionAlso: MgSO4Magnesium 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. | Drug | Intravenous Magnesium Sulfate |
| 0.9 % sodium chlorideAlso: Normal Saline0.9% normal saline was administered intravenously using an identical volume and infusion rate to the magnesium sulfate intervention and was delivered using a syringe pump. | Drug | 0.9% Sodium Chloride |
Primary outcome
Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire
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.
2 secondary outcomes
Change in Serum Interleukin-6 Concentration
Time frame: Baseline to 1 hour after completion of UGIE
Change in Total Serum Calcium Concentration
Time frame: Baseline to 1 hour after completion of UGIE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Procedural Pain
Not yet recruiting
Effects of Family-Proxy-Selected Natural Sound Therapy Versus Standardized Natural Sound and Noise Reduction on Procedural Pain During Endotracheal Suctioning in Non-Communicative Mechanically Ventilated Adults: A Four-Arm Randomized Controlled Trial
Procedural Pain During Endotracheal Suctioning
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
RecruitingObservational study
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
Procedural Pain, Procedural Sedation and Analgesia
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruiting
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
Procedural Pain in Newborns
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiqih E Putra, S.Ked principal investigator
Faculty of Medicine, Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate (MgSO4) infusion and 0.9 % sodium chloride in people with Procedural Pain, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Endoscopic Esophageal Symptom Severity Assessed Using the Modified Esophageal Symptoms Questionnaire (time frame: 1, 4, 24, and 48 hours after completion of Upper Gastrointestinal Endocopy (UGIE) with biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.