Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous magnesium sulfate, Normal saline infusion.
- Who it may be relevant to
- Registry conditions: Opioid Consumption, Multimodal Analgesia, Acute Appendicitis, Complication of Treatment. Basic parameters: 18 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
Pain in the perioperative period is associated with surgical stimuli but also with laryngoscopy and intubation. According to the currently applicable ERAS (Enhanced Recovery After Surgery) doctrine, the recommended method of anesthesia is multimodal, low-opioid anesthesia. The essence of multimodal anesthesia is to combine different methods (e.g. general and regional anesthesia) and various anesthetic drugs in order to reduce the intraoperative use of opioids. The one of commonly used co-analgetic is magnesium. The use of magnesium infusion before induction of anesthesia may enhance the analgesic effect of the opioid administered before intubation. In current guidelines for the relief of acute pain in children, magnesium sulfate may be considered as a coanalgesic. It is based only on expert consensus opinion and/or data from small studies, retrospective studies, registries.
According to available data magnesium sulfate is superior to placebo in decreasing analgesic consumption and pain scores during the first 48 h after operation without any adverse effects in children with cerebral pals. In other groups of pediatric patients, the effectiveness of magnesium as a co-analgetic has not been proven. High quality randomized controlled trials are still missing.
The primary outcome of this study is to assess opioid consumption during the laparoscopic appendectomy. Number of patients requiring rescue dose of opioids will be measured.
The secondary aim is to examine total intraoperative fentanyl consumption, fluctuations of heart rate and blood pressure, metabolic, hormonal and inflammatory response (glucose, cortisol and IL-6 concentrations) and occurrence of side effects that may result from magnesium intake (decrease in blood pressure, bradycardia or allergic reaction).
In the pediatric population, the optimal perioperative magnesium dosage is 50 mg/kg as a bolus followed by an infusion of 15 mg/kg/hour until the end of the operation.
The general aim of the study is to evaluate the analgesic efficacy of intravenous magnesium sulfate as an adjunct to standard general anesthesia (involving intravenous induction and opioid with sevoflurane maintenance) for intubation and surgical trauma during anesthesia for laparoscopic appendectomy in children.
Interventions
- Drug Intravenous magnesium sulfate
Intraoperative intravenous magnesium sulfate infusion. - Drug Normal saline infusion
Intraoperative intravenous normal saline infusion.
Primary outcome measures
- Number of patients requiring rescue dose of opioids. [Time frame: From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).]
Secondary outcome measures (7)
- The requirement for opioids during anesthesia [Time frame: From operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).]
- Hemodynamic reaction to tracheal intubation [Time frame: Pre-intubation - immediately after intubation.]
- Metabolic response to laparoscopic procedure [Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.]
- Hormonal response to laparoscopic procedure [Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.]
- Inflammatory response to laparoscopic procedure [Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.]
- Magnesium blood level [Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.]
- Side effects of magnesium sulfate [Time frame: From the beginning of magnesium sulfate application until transfer to the postanesthesia care unit (10 minutes after extubation).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Poland · 1 center
- Uniwersity Clinic Centre of Medical Uniwersity of Warsaw — Warsaw
Publications
- Cettler M, Zielinska M, Rosada-Kurasinska J, Kubica-Cielinska A, Jarosz K, Bartkowska-Sniatkowska A. Guidelines for treatment of acute pain in children - the consensus statement of the Section of Paediatric Anaesthesiology and Intensive Therapy of the Polish Society of Anaesthesiology and Intensive Therapy. Anaesthesiol Intensive Ther. 2022;54(3):197-218. doi: 10.5114/ait.2022.118972. PMID 36189904
- Benzon HA, Shah RD, Hansen J, Hajduk J, Billings KR, De Oliveira GS Jr, Suresh S. The Effect of Systemic Magnesium on Postsurgical Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial. Anesth Analg. 2015 Dec;121(6):1627-31. doi: 10.1213/ANE.0000000000001028. PMID 26501831
- O'Flaherty JE, Lin CX. Does ketamine or magnesium affect posttonsillectomy pain in children? Paediatr Anaesth. 2003 Jun;13(5):413-21. doi: 10.1046/j.1460-9592.2003.01049.x. PMID 12791115
Identifiers
NCT: NCT06563349 · Mg01