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Recruiting NCT07427446

Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

Phase IV Interventional Emergence Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine and Midazolam, Ketamine and Midazolam.
Who it may be relevant to
Registry conditions: Emergence Delirium. Basic parameters: 2 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Dexmedetomidine and Midazolam
    Children will receive Dexamedetomedine and Midazolam
  • Drug Ketamine and Midazolam
    Children will receive Ketamine and Midazolam

Primary outcome measures

  • Emergence delirium [Time frame: 30 minutes post-anesthesia]

Eligibility criteria

Inclusion criteria

  • Scheduled for elective cardiac catheterization under general anesthesia.

Exclusion criteria

  • neurological disorder, psychiatric disease, or current psychoactive medication.
  • allergy.
  • significant systemic comorbidities.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Kasralainy Hospital — Cairo

Identifiers

NCT: NCT07427446 · MS-664-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗