Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy

NCT06563349 | Recruiting Phase 4

• 1 other identifier: Mg01
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Consumption; Multimodal Analgesia; Acute Appendicitis; Complication of Treatment

Keywords

multimodal analgesia; magnesium sulfate; laparoscopic appendectomy; children; pediatric population; adjuvant; metabolic stress response; hormonal response; inflammatory response

Outcome Measures

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.

  From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).

Secondary Outcomes (7)

• The requirement for opioids during anesthesia

  From operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).

• Hemodynamic reaction to tracheal intubation

  Pre-intubation - immediately after intubation.

• Metabolic response to laparoscopic procedure

  From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.

• Hormonal response to laparoscopic procedure

  From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.

• Inflammatory response to laparoscopic procedure

  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

  From the time of extubation until the time of discharge from the hospital, through study completion, an average of 3 days.

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

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.

Drug: Intravenous magnesium sulfate

Control

PLACEBO COMPARATOR

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.

Drug: Normal saline infusion

Interventions

Intravenous magnesium sulfate DRUG

Intraoperative intravenous magnesium sulfate infusion.

Also known as: IVM (intravenous magnesium)

Magnesium Sulfate

Normal saline infusion DRUG

Intraoperative intravenous normal saline infusion.

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Uniwersity Clinic Centre of Medical Uniwersity of Warsaw

Warsaw, 02-091, Poland

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Intravital Microscopy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Izabela Pągowska-Klimek, prof.

  Medical University of Warsaw

  STUDY DIRECTOR

Central Study Contacts

Alicja Kuczerowska, MD

CONTACT

601666694; alicja.kuczerowska@uckwum.pl

Maciej Kaszyński, PhD

CONTACT

maciej.kaszyński2@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The drug or placebo (normal saline) will be placed in a syringe by the principal investigator. Only principal investigator will be aware of the participants allocation. The principal investigator will not be involved in the process of: recruitment, providing an intervention, or outcomes assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 20, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The study protocol will be available to other researchers continuously after its publication. The Clinical Study Report will be published after the study completion.
• Access Criteria: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.

Locations

PL (1)