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Phase 4
Age: 2Years - 6Years
All Genders
ID07427446

Comparing Dexmedetomidine-Midazolam and Ketamine-Midazolam to Prevent Emergence Delirium in Children Aged 2 to 6 Undergoing Heart Catheterization

Led by Kasr El Aini Hospital · Updated on 2026-02-27

50

Participants Needed

1

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two drug combinations on emergence delirium in children aged 2 to 6 years undergoing heart catheterization. The study compares Dexmedetomidine plus Midazolam to Ketamine plus Midazolam during sevoflurane anesthesia. This trial is a randomized, controlled study conducted at Kasr El Aini Hospital to understand which combination might influence emergence delirium after anesthesia. Children will be randomly assigned to one of two groups. Group DM will receive Dexmedetomidine 1 gkg IV over 10 minutes and Midazolam 0.1 mgkg IV at induction, followed by a continuous infusion of Dexmedetomidine 0.5 gkgh and Midazolam 0.1 mgkgh. Group KM will receive Ketamine 1 mgkg IV and Midazolam 0.1 mgkg IV at induction, followed by continuous infusion of Ketamine 1 mgkgh and Midazolam 0.1 mgkgh. Participants will be closely monitored during and after the procedure for signs of emergence delirium, which will be assessed 30 minutes after anesthesia. The trial uses quadruple masking to ensure unbiased results. The study will continue until March 2027, and children will receive scheduled care throughout the process under medical supervision.

CONDITIONS

Brief Title

Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

Research Team

A

Ahmed Elhaddad, Ass.prof.

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