Actively Recruiting

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

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

Age: 2Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for elective cardiac catheterization under general anesthesia
  • Children aged between 2 and 6 years
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure day

Participants receive dexmedetomidine-midazolam or ketamine-midazolam during cardiac catheterization under general anesthesia.

1 visit (in-person)

Follow-up

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

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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

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