Actively Recruiting
Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.
Led by Kasr El Aini Hospital · Updated on 2026-02-27
50
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
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 g/kg IV over 10 minutes) and Midazolam (0.1 mg/kg IV) at induction, followed by a continuous infusion of Dexmedetomidine (0.5 g/kg/h) and Midazolam (0.1 mg/kg/h). Group KM will receive Ketamine (1 mg/kg IV) and Midazolam (0.1 mg/kg IV) at induction, followed by continuous infusion of Ketamine (1 mg/kg/h) and Midazolam (0.1 mg/kg/h). 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for elective cardiac catheterization under general anesthesia
- Children aged between 2 and 6 years
You will not qualify if you...
- Neurological disorder, psychiatric disease, or current use of psychoactive medication
- Allergy to study medications
- Significant systemic comorbidities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants receive dexmedetomidine-midazolam or ketamine-midazolam during cardiac catheterization under general anesthesia.
1 visit (in-person)
Duration - 30 minutes post-anesthesia
Participants are monitored for emergence delirium and recovery within 30 minutes post-anesthesia.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Kasralainy Hospital
Cairo, Egypt
Actively Recruiting
Research Team
A
Ahmed Elhaddad, Ass.prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here