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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

ConditionSedation and Analgesia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-12
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 2-12 years, male or female

Weight ≥ 10 kg

Secundum atrial septal defect (ASD) suitable for device closure

Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Group KP: Ketamine + Propofol.Active comparator 1 intervention
Group B: Group DP: Dexmedetomidine + PropofolActive comparator 1 intervention

Trial outcomes

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.

Time frame
2 hours

Secondary outcomes

1

Mean Heart Rate

Heart rate (bpm) measured during the procedure and recovery period.

Time frame
2 hours
2

Mean Arterial Pressure

Mean arterial pressure ( mmHg) measured during the procedure and recovery period.

Time frame
2 hours
3

Recovery time

Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria.

Time frame
2 hours
4

Adequate Sedation rate

Percentage of participants achieving the target level of sedation throughout the procedure without requiring a change in the assigned sedation regimen.

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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