a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts

NCT07669012 | Recruiting Phase 1 DMC

• 1 other identifier: FMASU MD352/2025
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts

Conditions

Sedation and Analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory complications

  Percentage of participants experiencing one or more respiratory complications (apnea, hypoxemia, atelectasis, hypercapnia, or need for advanced airway management) during the study period.

  2 hours

Secondary Outcomes (4)

• Mean Heart Rate

  2 hours

• Mean Arterial Pressure

  2 hours

• Recovery time

  2 hours

• Adequate Sedation rate

  2 hours

Study Arms (2)

Group KP: Ketamine + Propofol.

ACTIVE COMPARATOR

Group that will receive Propofol and ketamine

Drug: Ketamine + propofol

Group DP: Dexmedetomidine + Propofol

ACTIVE COMPARATOR

Group that will receive Dexmedetomidine and Propofol

Drug: Dexmedetomidine + propofol

Interventions

Ketamine + propofol DRUG

Ketamine IV bolus 1 mg/kg (range commonly 0.5-1.5 mg/kg) administered as an initial bolus to provide analgesia and hemodynamic support; followed by a propofol infusion 100-150 µg/kg/min (titrated to clinical effect). Rescue propofol boluses 0.5 mg/kg IV may be given for inadequate sedation

Also known as: Sedation

Group KP: Ketamine + Propofol.

Dexmedetomidine + propofol DRUG

Dexmedetomidine loading dose 1 µg/kg over 10 minutes (range 0.5-1 µg/kg reported) followed by maintenance infusion per clinical need; co-administration of propofol infusion 100-150 µg/kg/min, titrated to the sedation target. Rescue propofol boluses 0.5 mg/kg IV may be used for breakthrough movement or inadequate sedation

Also known as: Sedation

Group DP: Dexmedetomidine + Propofol

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-12 years, male or female
• Weight ≥ 10 kg
• Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including:
• Secundum atrial septal defect (ASD) suitable for device closure
• Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure
• Patent ductus arteriosus (PDA) closure
• Procedure performed with transthoracic or transesophageal echocardiographic guidance according to the cardiology team's practice
• ASA physical status II-III
• Written informed consent obtained from a parent or legal guardian

You may not qualify if:

• Cyanotic congenital heart disease
• Complex congenital cardiac lesions
• Risk of pulmonary hypertensive crisis
• Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team
• Baseline oxygen requirement \> 2 L/min
• Use of noninvasive ventilation
• Known allergy or intolerance to ketamine, dexmedetomidine, or propofol
• Significant hepatic impairment
• Significant renal impairment
• Advanced atrioventricular block
• Clinically significant bradyarrhythmia
• Uncontrolled epilepsy
• Raised intracranial pressure
• Severe obstructive sleep apnea
• Craniofacial anomalies associated with anticipated difficult airway management

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: June 25, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-05

Locations

EG (1)