Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients

NCT06977425 | Completed

• 1 other identifier: FMASU MS112/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effectiveness of intraoperative magnesium sulfate versus dexmedetomidine infusions on emergence agitation that follows anesthesia using sevoflurane immediately and after 30 min in the post-anesthesia care unit (PACU), regarding Pediatric Anesthesia Emergence Delirium Scale (PAED), Richmond agitation sedation scale (RASS), and hemodynamics

Conditions

Magnesium Sulphate; Dexmedetomidine; Emergence Agitation; Pediatric Patients

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium Scale

  Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED Scale consists of five characteristics that are each scored by using a 5-point Likert scale: * The child makes eye contact with the caregiver * The child is aware of his or her surroundings * The child's actions are purposeful, * The child is restless * The child is inconsolable We set the threshold score for the presence of pediatric emergence delirium using the PAED Scale at a score higher than or equal to 10 based on the sensitivity and specificity reported in the literature.

  30 minutes postoperatively

Secondary Outcomes (3)

• Richmond agitation sedation scale (RASS)

  30 minutes postoperatively

• Heart rate

  30 minutes postoperatively

• Blood pressure

  30 minutes postoperatively

Study Arms (2)

Magnesium sulphate group

EXPERIMENTAL

Patients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery.

Drug: Magnesium sulphate

Dexmedetomidine group

EXPERIMENTAL

Patients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation.

Drug: Dexmedetomidine

Interventions

Magnesium sulphate DRUG

Patients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery.

Magnesium sulphate group

Dexmedetomidine DRUG

Patients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation.

Dexmedetomidine group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 4 to 8 years old.
• Both sexes.
• Patients American Society of Anesthesiologists (ASA) Physical Status I to II.
• Duration of surgery: not exceeding two hours

You may not qualify if:

• Legal guardian refusal.
• Neurological abnormalities, such as cerebral palsy.
• Any physical and/or developmental challenge.
• Patients on sedatives, anticonvulsants, or any medications that may alter conscious level in children.
• Coexisting renal or cardiovascular diseases.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Magnesium Sulfate; Dexmedetomidine

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; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 18, 2025
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: February 10, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 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)