Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07427446

Enrollment

Registered

2026-02-23

Start date

2026-02-01

Completion date

2027-03-01

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Keywords

Emergence delirium, Dexmedetomidine, Ketamine, Midazolam, sevoflurane

Brief summary

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

DRUGDexmedetomidine and Midazolam

Children will receive Dexamedetomedine and Midazolam

DRUGKetamine and Midazolam

Children will receive Ketamine and Midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Inclusion criteria

* Scheduled for elective cardiac catheterization under general anesthesia.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Emergence delirium	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.

Countries

Egypt

Contacts

CONTACTAhmed Elhaddad, Ass.prof.

drblacksmith@gmail.com01224042847

PRINCIPAL_INVESTIGATORAhmed Elhaddad, Ass.prof.

Faculty of medicins,Cairo university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026