drugset / Trial / NCT06077539

Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics

NCT06077539

Phase 1/2 Unknown 100 enrolled Cairo University
RandomizedParallel-groupQuadruple-blindHealth-services research

Summary

Emergence agitation (EA) is a post-operative behavioral disturbance was first reported in early 1960s. EA is a term used to describe non purposeful restlessness and agitation, thrashing, crying or moaning, disorientation and incoherence during early stage of recovering from general anesthesia in children, especially those receiving sevoflurane. Generally, the incidence of EA following sevoflurane anesthesia varies from 10% to 66% and is more common in pre-school children. EA is generally short lived without obvious aftereffect. However, it still accompanies with risk of self-injury, and requires extra nursing care, which may delay the discharge and increase the cost of medical care Emergence agitation is diagnosed by a final composite score of greater than or equal to 10 on the Pediatric Anesthesia Emergence Delirium Scale (PAED).(

Timeline

Start
2023-09-20
Primary completion
2024-04-15
Completion
2024-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg
Comparator Ketamine Small molecule 1 mg/kg Intravenous
Comparator Magnesium Sulfate Other / unclassified 10 mg/kg Intravenous

Indications