Oral Versus Intravenous Magnesium on Emergence Delirium

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Children; Emergence Delirium; Adenotonsillectomy; Magnesium
• Intervention / Treatment: Drug: Magnesium glycinate; Drug: Magnesium sulfate injection; Other: Oral juice and intravenous saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Osama M Rehab, MD; Phone Number: 002 +201095210806; Email: osamarehab@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31527
      • Tanta University Hospitals
      • Contact: Osama M Rehab, MD; Phone Number: 002 +201095210806; Email: osamarehab@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral magnesium group; cases will receive preoperative oral magnesium dose of 150 mg at two hours before surgery.	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.
Experimental: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of emergence delirium	Pediatric Anesthesia Emergence Delirium scale scores will be recorded	Up to 1 hour after surgery.
Postoperative pain	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	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	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	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	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	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	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	Postoperative nausea and vomiting , hypotension, bradycardia will be recorded	Up to 1 hour after surgery.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: June 13, 2026
• First Submitted That Met QC Criteria: June 13, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Sulfur Compounds; Inorganic Chemicals; Sulfur Acids; Sulfates; Sulfuric Acids; Magnesium Compounds; Magnesium Sulfate; magnesium diglycinate
• Other Study ID Numbers: 36265PR76/5/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No