NCT07082894

Effect of Preoperative Oral Magnesium on Emergence Agitation

The Effect of Preoperative Oral Magnesium on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Double Blind Randomized Placebo Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. 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 agitation in children, only intraoperative intravenous 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, the investigators will use magnesium via oral route before surgery as they hypothesize that the pre-emptive administration of the drug may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may explain its prophylactic benefit against emergence agitation.

Conditions

• Magnesium
• Emergence Agitation
• Adenotonsillectomy

Interventions

Type	Name	Description
DRUG	Magnesium	preoperative oral magnesium dose of 120 mg at one hour before surgery will be given.
OTHER	Placebo control	preoperative oral lemon juice at one hour before surgery will be given.

Timeline

• Start date: 2025-07-25
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-07-24
• Last updated: 2026-04-03

Locations

1 site across 1 country: Egypt