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Regain of consciousness in dexmedetomidine-propofol vs ketamine-propofol in cardiac catheterisation in paediatric population

Comparative evaluation of regain of consciousness in dexmedetomidine-propofol vs ketamine-propofol in paediatric cardiac catheterisation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/01/039162
Enrollment
56
Registered
2022-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: PCS- Health Condition 2: 4- Measurement and Monitoring Health Condition 3: 4- Measurement and Monitoring

Interventions

Intervention1: dexmedetomidine -propofol: Dexmedetomidine-1mcg/kg/hr for 10min and then 0.5mcg/kg/hr Propofol- 1mg/kg Intervention2: Ketamine-propofol: Ketamine- 1mg/kg for 10min and then 1mg/kg/hr

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Both cyanotic and acyanotic heart disease children 2.Weight 5-20 kg, both genders 3.Paediatric patient undergoing sedation for cardiac catheterisation procedures including device closure and cath study with duration >30 min and

Exclusion criteria

Exclusion criteria: 1.Patients already on mechanical ventilation 2.Patients requiring supplemental oxygen in pre op 3.Patients already on CPAP 4.Patients on ionotrops 5.Children with Downs syndrome

Design outcomes

Primary

MeasureTime frame
Regain of consciousness Timepoint: Minutes

Secondary

MeasureTime frame
1.Additional propofol requirement 2.Respiratory depression 3.Agitation 4.Inotropic requirement 5.Cardiac arrhythmia 6.Intubation requirement Timepoint: Baseline, 5min, 10min, 15min,20min, 25min, 30min, 35min, 40min, 45min, 50min, 55min, 60min, 70min,80min,90min, 100min,120min

Countries

India

Contacts

Public ContactPriya

Post Graduate Institute of Medical Education and Research

dr.sundernegi@gmail.com9888446388

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026