Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
NCT Number: NCT06563349
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Opioid Consumption|Multimodal Analgesia|Acute Appendicitis|Complication of Treatment
Interventions: DRUG: Intravenous magnesium sulfate|DRUG: Normal saline infusion
Sponsor: Medical University of Warsaw
Sex: ALL
Age: CHILD, ADULT
Enrollment: 188
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2027-10-01
Locations: Uniwersity Clinic Centre of Medical Uniwersity of Warsaw, Warsaw, 02-091, Poland

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.

Primary Outcome Measures: Number of patients requiring rescue dose of opioids., Patients who experience a 20% increase in BP (Blood Pressure) or HR (Heart Rate) from baseline during surgery and the early post-extubation period will receive a bolus of fentanyl (1 mcg/kg) as rescue analgesia. The number of these patients will be compared between the groups.

Baseline parameters will be recorded after premedication with an IV bolus of 0.05 mg/kg midazolam, just before intubation., From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).
Secondary Outcome Measures: The requirement for opioids during anesthesia, Total amount of fentanyl in micrograms per kilogram of body weight used during anesthesia (dose for induction of anesthesia + doses added during surgery and in the early post-extubation period)., From operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).|Hemodynamic reaction to tracheal intubation, A change in arterial blood pressure of more than 20% from baseline will be noted, and the fractions of these patients in each group will be compared. Baseline parameters will be recorded after premedication with an IV bolus of 0.05 mg/kg midazolam, just before intubation., Pre-intubation - immediately after intubation.|Metabolic response to laparoscopic procedure, Glucose \[mg/dl\] levels will be measured and compared before and after laparoscopic procedure.

The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application., From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.|Hormonal response to laparoscopic procedure, Cortisol levels \[mcg/dl\] will be measured and compared before and after laparoscopic procedure.

The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application., From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.|Inflammatory response to laparoscopic procedure, IL-6 levels \[pg/ml\] will be measured and compared before and after laparoscopic procedure.

The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application., From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.|Magnesium blood level, Magnesium level \[mg/dl\] will be measured after initial bolus and just before the end of its infusion.

The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application. Magnesium infusion will be discontinued after the second blood sample is collected., From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.|Side effects of magnesium sulfate, Side effects of magnesium sulfate will be assessed by recording the rates of the following complications: hypotension \& bradycardia (both defined as 2 SD (standard deviation) below the 50th percentile for age), allergic reaction. Need to discontinue the magnesium sulfate/placebo infusion due to side effects.

Need to administer calcium gluconate., From the beginning of magnesium sulfate application until transfer to the postanesthesia care unit (10 minutes after extubation).
Other Outcome Measures: Length of stay in the hospital after completing anesthesia, Length of stay in the hospital after completing anesthesia is defined as the time period from extubation (endotracheal tube removal) to discharge from the hospital. The mean length of hospital stay in the control and study groups will be compared., From the time of extubation until the time of discharge from the hospital, through study completion, an average of 3 days.