NCT06563349 Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
| NCT ID | NCT06563349 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Warsaw |
| Condition | Opioid Consumption |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 188 participants in total. It began in 2024-09-09 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Magnesium sulfate is one of the most commonly used co-analgetics. Its antinociceptive effect is related to antagonizing NMDA (N-methyl-D-aspartate) receptors of the nervous system, has an anti-inflammatory effect by reducing the concentration of IL-6 (interleukin 6) and tumor necrosis factor alpha. In adult patients, the need for morphine in the perioperative period is reduced when magnesium infusion is used. In current guidelines for treatment of acute pain in children, magnesium sulfate may be considered as a co-analgetic. However, the strength of such a recommendation is low due to the lack of reliable scientific research confirming the effectiveness of magnesium infusion in the pediatric population. The aim of this study is to evaluate the efficacy of intravenous magnesium sulfate infusion on the opioid consumption, the circulatory, metabolic and hormonal response to intubation and surgical trauma during anesthesia for laparoscopic appendectomy in children.
Eligibility Criteria
Inclusion Criteria: * ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency) * Patients undergoing laparoscopic appendectomy Exclusion Criteria: * Allergy to the magnesium sulfate or the excipient * Hypermagnesemia * Renal failure (GFR \<30 ml/min) * Myasthenia gravis * Preoperative atrioventricular block * Hypotension * The use of digitalis glycosides * The use of oral anticoagulants * ASA physical status class 4E or higher * Chronic treatment with analgesics * Legal guardians or patient refusal
Contact & Investigator
Izabela Pągowska-Klimek, prof.
STUDY DIRECTOR
Medical University of Warsaw
Frequently Asked Questions
Who can join the NCT06563349 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 18 Years, studying Opioid Consumption. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06563349 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06563349 currently recruiting?
Yes, NCT06563349 is actively recruiting participants. Contact the research team at alicja.kuczerowska@uckwum.pl for enrollment information.
Where is the NCT06563349 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06563349 clinical trial?
NCT06563349 is sponsored by Medical University of Warsaw. The principal investigator is Izabela Pągowska-Klimek, prof. at Medical University of Warsaw. The trial plans to enroll 188 participants.