Effect of Preoperative Oral Magnesium on Emergence Agitation

NCT ID: NCT07082894

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2026-01-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Magnesium group

cases will receive preoperative oral magnesium dose of 120 mg at one hour before surgery

Group Type: EXPERIMENTAL

Magnesium

Intervention Type: DRUG

preoperative oral magnesium dose of 120 mg at one hour before surgery will be given.

Control group

cases will receive oral lemon juice at one hour before surgery.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: OTHER

preoperative oral lemon juice at one hour before surgery will be given.

Interventions

Magnesium

preoperative oral magnesium dose of 120 mg at one hour before surgery will be given.

Intervention Type: DRUG

Placebo control

preoperative oral lemon juice at one hour before surgery will be given.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Both gender
• 4 to 7 years age
• American Society of Anesthesiologists (ASA) Physical Status I or II
• Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia

Exclusion Criteria

• Parents declined to participate in the trial
• Children with behavioral changes; neurological or psychiatric diseases
• Physical or developmental delay
• Sedative or anticonvulsant medication
• Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
• Allergy to magnesium

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Emad Eissa

lecturer of anesthesiology, surgical intensive care and pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Radwa E Eissa, MD

Role: CONTACT

radwa.emad@med.tanta.edu.eg

01007473944 ext. 002

Facility Contacts

Radwa E Eissa, MD

Role: primary

radwa.emad@med.tanta.edu.eg

+201007473944 ext. 002

Other Identifiers

36264PR1217/5/25

Identifier Type: -

Identifier Source: org_study_id