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

NCT ID: NCT06977425

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-02-10

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

Detailed Description

Emergence agitation (EA) is a postoperative phenomenon that occurs in children after sevoflurane anesthesia, with an occurrence rate of up to 80%.

Dexmedetomidine acts on α-2 adrenergic receptors, producing sedation and hypnosis with anxiolytic effects, without a clinically significant depressive impact on heart rate, blood pressure, and respiratory rate, complementing an earlier study suggesting the possible effective and safe use of dexmedetomidine as a part of anesthesia care to prevent emergence agitation in children.

Magnesium sulfate also has been reported to decrease the incidence and severity of Emergence agitation and the need for postoperative rescue doses of analgesia in children, and its use was not associated with increased postoperative side effects or delayed recovery.

Conditions

Magnesium Sulphate; Dexmedetomidine; Emergence Agitation; Pediatric Patients

Study Design

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

Study Groups

Magnesium sulphate group

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.

Group Type: EXPERIMENTAL

Magnesium sulphate

Intervention Type: 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.

Dexmedetomidine group

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Interventions

Magnesium sulphate

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.

Intervention Type: DRUG

Dexmedetomidine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Esraa medhat Ezzat Mohamed

Resident of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS112/2024

Identifier Type: -

Identifier Source: org_study_id