Clinical Trials Directory

Trials / Completed

CompletedNCT06977425

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
4 Years – 8 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGMagnesium sulphatePatients 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.
DRUGDexmedetomidinePatients 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.

Timeline

Start date
2024-04-01
Primary completion
2024-11-01
Completion
2025-02-10
First posted
2025-05-18
Last updated
2025-05-18

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06977425. Inclusion in this directory is not an endorsement.