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

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

Study Overview

• Status: Recruiting
• Conditions: Sedation and Analgesia
• Intervention / Treatment: Drug: Ketamine + propofol; Drug: Dexmedetomidine + propofol

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain shams university hospital
    • Contact: Noha Tarek Hassan; Phone Number: 01000667030; Email: Noha.Hassan@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• BMI > 97th percentile when judged to confer high risk of sedation-related airway obstruction
• Current beta-blocker use
• Current clonidine use
• Acute upper respiratory tract infection within 2 weeks before the procedure
• Emergency or add-on procedures
• Anticipated procedure duration < 20 minutes
• Anticipated procedure duration > 3 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group KP: Ketamine + Propofol.; Group that will receive Propofol and ketamine	Drug: Ketamine + propofol; 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; Other Names: Sedation
Active Comparator: Group DP: Dexmedetomidine + Propofol; Group that will receive Dexmedetomidine and Propofol	Drug: Dexmedetomidine + propofol; 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; Other Names: Sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Heart Rate	Heart rate (bpm) measured during the procedure and recovery period.	2 hours
Mean Arterial Pressure	Mean arterial pressure ( mmHg) measured during the procedure and recovery period.	2 hours
Recovery time	Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria.	2 hours
Adequate Sedation rate	Percentage of participants achieving the target level of sedation throughout the procedure without requiring a change in the assigned sedation regimen.	2 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: June 20, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Phenols; Benzene Derivatives; Dexmedetomidine; Propofol; Ketamine
• Other Study ID Numbers: FMASU MD352/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No