Oral Versus Intravenous Magnesium on Emergence Delirium

NCT07655817 | Recruiting Phase 2

• 1 other identifier: 36265PR76/5/26
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Magnesium; Emergence Delirium; Children; Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence delirium

  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.

Secondary Outcomes (9)

• Severity of emergence delirium

  Up to 1 hour after surgery.

• Postoperative pain

  Up to 1 hour after surgery.

• Parental separation anxiety

  Perioperative

• Mask acceptance

  Perioperative

• The total dose of rescue propofol

  Up to 1 hour after surgery.

Study Arms (3)

Oral magnesium group

EXPERIMENTAL

cases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery.

Drug: Magnesium glycinate

Intravenous magnesium group

EXPERIMENTAL

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.

Drug: Magnesium sulfate injection

Control group

PLACEBO COMPARATOR

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.

Other: Oral juice and intravenous saline

Interventions

Magnesium glycinate DRUG

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.

Oral magnesium group

Magnesium sulfate injection DRUG

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.

Intravenous magnesium group

Oral juice and intravenous saline OTHER

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.

Control group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

magnesium diglycinate; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Osama M Rehab, MD

CONTACT

+201095210806; osamarehab@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Model Details: Parallel assignment

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)