Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on 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 →
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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