NCT07427446

Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups. Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)

Detailed description

Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups. Group DM (Dexmedetomidine + Midazolam) will receive dexmedetomidine 1 µg/kg IV over 10 minutes and midazolam 0.1 mg/kg IV as a bolus concomitant with induction, followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h and midazolam at 0.1 mg/kg/h for maintenance. Group KM (Ketamine + Midazolam) will receive ketamine 1 mg/kg IV and midazolam 0.1 mg/kg IV as a bolus for induction, followed by a continuous infusion of ketamine at 1 mg/kg/h and midazolam at 0.1 mg/kg/h.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine and Midazolam	Children will receive Dexamedetomedine and Midazolam
DRUG	Ketamine and Midazolam	Children will receive Ketamine and Midazolam

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-02-23
• Last updated: 2026-02-27

Locations

1 site across 1 country: Egypt