Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

NCT07427446 | Recruiting Phase 4 DMC

• 1 other identifier: MS-664-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Emergence Delirium

Keywords

Emergence delirium; Dexmedetomidine; Ketamine; Midazolam; sevoflurane

Outcome Measures

Primary Outcomes (1)

• Emergence delirium

  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.

  30 minutes post-anesthesia

Study Arms (2)

Dexmedetomidine-Midazolam

ACTIVE COMPARATOR

Children will receive Dexmedetomidine + Midazolam

Drug: Dexmedetomidine and Midazolam

ketamine-Midazolam

ACTIVE COMPARATOR

Children will receive ketamine + Midazolam

Drug: Ketamine and Midazolam

Interventions

Dexmedetomidine and Midazolam DRUG

Children will receive Dexamedetomedine and Midazolam

Also known as: Precedex and Dormicum

Dexmedetomidine-Midazolam

Ketamine and Midazolam DRUG

Children will receive Ketamine and Midazolam

Also known as: katalar and Dormicum

ketamine-Midazolam

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Scheduled for elective cardiac catheterization under general anesthesia.

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Midazolam; Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ahmed Elhaddad, Ass.prof.

  Faculty of medicins,Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Elhaddad, Ass.prof.

CONTACT

01224042847; drblacksmith@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstent Professor

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)