Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563349
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 andor 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 mgkg as a bolus followed by an infusion of 15 mgkghour 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
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 mgkg as a bolus followed by an infusion of 15 mgkghour 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None