The Effect of Intravenous Magnesium Infusion on the Opioid Consumption, the Circulatory, Metabolic and Hormonal Response to Intubation and Surgical Trauma During Anaesthesia for Laparoscopy in Children. Randomized Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:

• ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency)

• Patients undergoing laparoscopic appendectomy

Locations
Other Locations
Poland
Uniwersity Clinic Centre of Medical Uniwersity of Warsaw
RECRUITING
Warsaw
Contact Information
Primary
Alicja Kuczerowska, MD
alicja.kuczerowska@uckwum.pl
601666694
Backup
Maciej Kaszyński, PhD
maciej.kaszyński2@wum.edu.pl
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 188
Treatments
Experimental: Magnesium Sulfate
10% magnesium sulfate intravenous bolus of 0.5 ml/kg (maximum 20 ml) over 5 min before induction of anesthesia followed by magnesium sulfate infusion at 0.15 ml/kg/h (maximum 6 ml/h) intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
Placebo_comparator: Control
0.9% NaCl (sodium chloride) intravenous bolus of 0.5 ml/kg (maximum 20 ml) over 5 min before induction of anesthesia followed by 0.9% NaCl infusion at 0.15 ml/kg/h (maximum 5ml/h) intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
Sponsors
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov