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NCT Number: NCT07427446

Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

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)

Recruiting

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kasralainy Hospital

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for elective cardiac catheterization under general anesthesia.

Exclusion criteria

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

Treatment and study plan

Dexmedetomidine and Midazolam

Drug

Children will receive Dexamedetomedine and Midazolam

Other names: Precedex and Dormicum

Ketamine and Midazolam

Drug

Children will receive Ketamine and Midazolam

Other names: katalar and Dormicum

Primary outcomes

  1. Emergence delirium

    Time frame: 30 minutes post-anesthesia

    Incidence of emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium PAED scale. The scale consists of five behavioral items, each rated on a 5-point scale from 0 to 4(Eye contact, Purposefulness, Awareness, Restlessness, Inconsolability),Total scores range from 0 to 20.A PAED score ≥10 will be considered a clinically significant ED.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Elhaddad, Ass.prof.

CONTACT

[email protected]

01224042847

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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