Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-18
SponsorMedical University of Warsaw
About this trial
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
This trial does not accept healthy volunteersQualifiers
ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency)
Patients undergoing laparoscopic appendectomy
Disqualifiers
Allergy to the magnesium sulfate or the excipient
Hypermagnesemia
Renal failure (GFR <30 ml/min)
Myasthenia gravis
Trial design
Design model
Parallel
Treatments tested in this trial
Intravenous magnesium sulfate
DrugIntraoperative intravenous magnesium sulfate infusion.
Normal saline infusion
DrugIntraoperative intravenous normal saline infusion.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Magnesium SulfateExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).Secondary outcomes
1
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).
Time frame
From operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).2
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.
Time frame
Pre-intubation - immediately after intubation.3
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.
Time frame
From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.4
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.
Time frame
From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.Other outcomes
1
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.
Time frame
From the time of extubation until the time of discharge from the hospital, through study completion, an average of 3 days.Sponsors and contacts
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Source ClinicalTrials.gov