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

Not Applicable

Completed

• Conditions: Magnesium Sulphate; Dexmedetomidine; Emergence Agitation; Pediatric Patients
• Interventions: Drug: Magnesium sulphate; Drug: Dexmedetomidine

• Registration Number: NCT06977425
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-02-10
• Study First Submitted: 2025-04-04
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium sulphate group	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.
Dexmedetomidine group	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.

Primary Outcome Measures

Name	Time	Method
Pediatric Anesthesia Emergence Delirium Scale	30 minutes postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	30 minutes postoperatively	Blood pressure will be recorded from the start of injection till 30 minutes postoperatively.
Richmond agitation sedation scale (RASS)	30 minutes postoperatively	The Richmond agitation sedation scale (RASS) assesses five levels of sedation: * (5) unarousable with no response to voice or physical stimulation; * (4) deep sedation with no response to voice but movement to physical stimuli; * (3) moderate sedation with movement to voice but no eye contact; * (2) light sedation and briefly awakens (ie, less than 10 seconds) with eye contact to voice; * (1) drowsy (ie, not fully alert) but has sustained (ie, more than 10 seconds) awakening with eye contact to voice
Heart rate	30 minutes postoperatively	Heart rate will be recorded from the start of injection till 30 minutes postoperatively.

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt