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Recruiting NCT07655817

Oral Versus Intravenous Magnesium on Emergence Delirium

Phase II / Phase III Interventional Magnesium Emergence Delirium Children Adenotonsillectomy

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: Magnesium glycinate, Magnesium sulfate injection, Oral juice and intravenous saline.
Who it may be relevant to
Registry conditions: Magnesium, Emergence Delirium, Children, Adenotonsillectomy. Basic parameters: 4 years — 7 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
Egypt
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

Effect of Oral Versus Intravenous Magnesium on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Two-Center, Randomized, Double-Blind, Placebo-Controlled Study

Overview

This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia.

Detailed description

Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness.

Regarding its use as a preventive measure against emergence delirium in children, only intraoperative IV route was studied and the results of previous reports were inconsistent.

Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.

In this novel study, we will compare the use of magnesium via two different routes, either oral route before surgery or IV route after sevoflurane induction, regarding their preventive value against the occurrence of emergence delirium in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence delirium, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may suggest a prophylactic benefit against emergence delirium. So, we hypothesize that either oral or IV magnesium therapy may decrease the incidence of emergence delirium in this setting.

Interventions

  • Drug Magnesium glycinate
    cases will receive preoperative oral magnesium dose of 150 mg (10 ml of Magnesium Glycinate Liquid Trace syrup) at two hours before surgery, and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
  • Drug Magnesium sulfate injection
    cases will receive oral lemon juice (10 ml) at two hours before surgery, and will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
  • Other Oral juice and intravenous saline
    cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.

Primary outcome measures

  • Incidence of emergence delirium [Time frame: Up to 1 hour after surgery.]
Secondary outcome measures (9)
  • Severity of emergence delirium [Time frame: Up to 1 hour after surgery.]
  • Postoperative pain [Time frame: Up to 1 hour after surgery.]
  • Parental separation anxiety [Time frame: Perioperative]
  • Mask acceptance [Time frame: Perioperative]
  • The total dose of rescue propofol [Time frame: Up to 1 hour after surgery.]
  • The total dose of rescue fentanyl [Time frame: Up to 1 hour after surgery.]
  • Extubation time [Time frame: End of surgery.]
  • Negative behavior changes [Time frame: 24 hours after surgery.]
  • Side effects [Time frame: Up to 1 hour after surgery.]

Eligibility criteria

Inclusion criteria

  • Children aged 4 to 7 years
  • American Society of Anesthesiologist (ASA) Status I or II
  • Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.

Exclusion criteria

  • Parents declined to participate in the trial
  • Behavioral changes, neurological or psychiatric problems
  • Anticonvulsant or sedative drugs
  • Physical or developmental abnormalities
  • Allergies to magnesium
  • cardiovascular, renal, bone, or gastrointestinal diseases.

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
Prevention

Study locations

Egypt · 1 center
  • Tanta University Hospitals — Tanta

Identifiers

NCT: NCT07655817 · 36265PR76/5/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗