Trial intelligence / Profile preview

Oral vs IV Magnesium for Emergence Delirium in Children Undergoing Adenotonsillectomy

NCT07655817Phase 3

Key facts

Status
Recruiting
Start
Jul 2026
Primary completion
Dec 2026
Countries
1
Sponsor
Tanta University
Conditions
emergence delirium (ED)
01

Overview

Phase 3, randomised, double-blind trial of magnesium in emergence delirium (ED) (3 arms), sponsored by Tanta University. Primary endpoint: Incidence of emergence delirium. Started Jul 2026; status: recruiting.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Oral magnesium group

    Preoperative oral magnesium dose of 150 mg at two hours before surgery.

  • Intravenous magnesium group

    Intraoperative IV magnesium sulfate dose of 30 mg/kg over 10 minutes after induction of anesthesia.

  • Control group

    Oral lemon juice at two hours before surgery and intraoperative IV saline over 10 minutes after induction of anesthesia.

03

Who it enrols

Children aged 4-7 years with ASA Status I or II planned for adenotonsillectomy under sevoflurane anesthesia, excluding those with psychiatric/neurological problems, taking sedatives/anticonvulsants, or having cardiovascular, renal, bone, or GI diseases.

04

Endpoints

Primary

  • Incidence of emergence delirium

Secondary

  • Severity of emergence delirium

  • Postoperative pain

  • Parental separation anxiety

  • Mask acceptance

  • Total dose of rescue propofol

  • Total dose of rescue fentanyl

  • Extubation time

  • Negative behavior changes

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