Actively Recruiting

Phase 4
Age: 18Months - 18Years
All Genders
ID06563349

The Effect of Intravenous Magnesium Infusion on Opioid Use and Body Responses to Surgery During Anesthesia for Laparoscopic Appendectomy in Children

Led by Medical University of Warsaw · Updated on 2024-11-12

188

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how intravenous magnesium sulfate infusion affects opioid use and the body's circulatory, metabolic, and hormonal responses during anesthesia for laparoscopic appendectomy in children. Magnesium has antinociceptive and anti-inflammatory effects and is commonly used as a co-analgesic in adults. However, its effectiveness in children lacks strong scientific evidence, and this study aims to provide high-quality data on its use in pediatric surgery. The study compares two groups: one receiving magnesium sulfate as an intravenous bolus before anesthesia induction followed by continuous infusion during surgery, and the other receiving a placebo of normal saline in the same manner. The magnesium dose is 50 mg/kg as a bolus and 15 mg/kg/hour during the operation. The infusion stops before the patient is moved to the postanesthesia care unit. Participants will be monitored from tracheal intubation through postanesthesia care unit admission, with measurements including opioid consumption, heart rate and blood pressure changes, metabolic and hormonal markers (glucose, cortisol, IL-6), magnesium blood levels, and any side effects such as low blood pressure or allergic reactions. The primary outcome is the number of patients needing rescue opioid doses. Secondary outcomes include detailed intraoperative opioid use and physiological responses. The study will last until October 2027.

CONDITIONS

Brief Title

Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy

Who Can Participate

Age: 18Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status class 1E, 2E, or 3E (emergency)
  • Patients scheduled for laparoscopic appendectomy
Not Eligible

You will not qualify if you...

  • Allergy to magnesium sulfate or its excipients
  • Hypermagnesemia
  • Renal failure with GFR less than 30 ml/min
  • Myasthenia gravis
  • Preoperative atrioventricular block
  • Hypotension
  • Use of digitalis glycosides
  • Use of oral anticoagulants
  • ASA physical status class 4E or higher
  • Chronic treatment with analgesics
  • Refusal by patient or legal guardians

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of the laparoscopic appendectomy surgery

Participants receive intravenous magnesium sulfate or placebo infusion during anesthesia for laparoscopic appendectomy to evaluate opioid use and body responses to surgery.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 10 minutes after extubation

Participants are monitored for opioid use, side effects of magnesium sulfate, and recovery during transfer to the postanesthesia care unit.

1 postanesthesia care visit (in-person)

Trial Site Locations

Total: 1 location

1

Uniwersity Clinic Centre of Medical Uniwersity of Warsaw

Warsaw, Poland, 02-091

Actively Recruiting

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Research Team

A

Alicja Kuczerowska, MD

M

Maciej Kaszyński, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

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.

Maciej Cettler, Marzena Zielińska, Jowita Rosada-Kurasińska...

https://pubmed.ncbi.nlm.nih.gov/36189904

The Effect of Systemic Magnesium on Postsurgical Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial.

Hubert A Benzon, Ravi D Shah, Jennifer Hansen...

https://pubmed.ncbi.nlm.nih.gov/26501831