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Recruiting Phase 4 NCT06563349

Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy

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Trial Parameters

Condition Opioid Consumption
Sponsor Medical University of Warsaw
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 188
Sex ALL
Min Age 18 Months
Max Age 18 Years
Start Date 2024-09-09
Completion 2027-09-01
Interventions
Intravenous magnesium sulfateNormal saline infusion

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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

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