NCT Number: NCT06563349
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.
Interested in participating?
Request Info18 month–18 year
All sexes
Interventional
Phase 4
Warsaw, 02-091, Poland
Location status: Recruiting
Alicja Kuczerowska, MD
SUB_INVESTIGATOR
Izabela Pągowska-Klimek, prof.
CONTACT
Izabela Pągowska-Klimek, prof.
SUB_INVESTIGATOR
Maciej Kaszyński, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative intravenous magnesium sulfate infusion.
Other names: IVM (intravenous magnesium)
Intraoperative intravenous normal saline infusion.
Other names: Placebo
Time frame: From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).
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 operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).
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: Pre-intubation - immediately after 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: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
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.
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.
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.
Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
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.
Time frame: From the beginning of magnesium sulfate application until transfer to the postanesthesia care unit (10 minutes after extubation).
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.
Time frame: From the time of extubation until the time of discharge from the hospital, through study completion, an average of 3 days.
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.
Contact information is provided by the study sponsor or research team.
Alicja Kuczerowska, MD
CONTACT
601666694 ext. +48
Maciej Kaszyński, PhD
CONTACT
maciej.kaszyń[email protected]
Medical University of Warsaw
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05238506
Acute Appendicitis, Appendicitis
Warsaw, Poland
View Trial DetailsNCT07693270
Chemically-Induced Disorders, Mental Disorders
La Jolla, California, United States
View Trial DetailsNCT07361822
Agnosia, Nervous System Diseases
Beijing, China
View Trial DetailsNCT07553611
Arthroscopic Shoulder Surgery, Hemidiaphragmatic Paralysis
Antalya, Muratpaşa, Turkey (Türkiye)
View Trial Details