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Oral Versus Intravenous Magnesium on Emergence Delirium

1 juillet 2026 mis à jour par: Osama Rehab, Tanta University

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

360

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Egypte
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypte, 31527
        • Recrutement
        • Tanta University Hospitals
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Oral magnesium group
cases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery.
Médicament: 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.
Expérimental: Intravenous magnesium group
cases 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.
Médicament: 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.
Comparateur placebo: Control group
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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of emergence delirium
Délai: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale will be used and a score >12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium. it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour
Up to 1 hour after surgery.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Severity of emergence delirium
Délai: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale scores will be recorded
Up to 1 hour after surgery.
Postoperative pain
Délai: Up to 1 hour after surgery.
the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl
Up to 1 hour after surgery.
Parental separation anxiety
Délai: Perioperative
It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 was considered as 'acceptable' separation
Perioperative
Mask acceptance
Délai: Perioperative
The ease of mask acceptance will be graded using the Mask Acceptance Score at the time of induction of general anesthesia with sevoflurane. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 was considered 'satisfactory' mask acceptance.
Perioperative
The total dose of rescue propofol
Délai: Up to 1 hour after surgery.
Parental contact will be initiated as the first line management of delirium. If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered. This dose will be repeated after 15 min if the child still agitated. The total dose of rescue propofol will be recorded.
Up to 1 hour after surgery.
The total dose of rescue fentanyl
Délai: Up to 1 hour after surgery.
A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl. This dose will be repeated after 15 min if the child still in pain. The total dose of rescue fentanyl will be recorded
Up to 1 hour after surgery.
Extubation time
Délai: End of surgery.
At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned
End of surgery.
Negative behavior changes
Délai: 24 hours after surgery.
Post Hospitalization Behavior Questionnaire will be used to evaluate the child's baseline behavior before anesthesia and any negative behavioral changes at 24 hours postoperatively. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the Post Hospitalization Behavior Questionnaire items in comparison with the pre-anesthesia baseline values.
24 hours after surgery.
Side effects
Délai: Up to 1 hour after surgery.
Postoperative nausea and vomiting , hypotension, bradycardia will be recorded
Up to 1 hour after surgery.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tanta University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2026

Achèvement primaire (Estimé)

24 décembre 2026

Achèvement de l'étude (Estimé)

25 décembre 2026

Dates d'inscription aux études

Première soumission

13 juin 2026

Première soumission répondant aux critères de contrôle qualité

13 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 36265PR76/5/26

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The data will be available upon a reasonable request from the corresponding author.

Délai de partage IPD

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Critères d'accès au partage IPD

The data will be available upon a reasonable request from the corresponding author.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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