Health Condition 1: - Health Condition 2: Q278- Other specified congenital malformations of peripheral vascular system
Conditions
Interventions
Intervention1: Remifentanil-ketamine regimen: Intravenous ketamine 0.5 mg/kg will be given the induction of sedation followed by 0.1 g/kg/min remifentanil infusion which will be continued until the e
Sponsors
Department of Anesthesia and Intensive Care
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3 to 12 years ASA 1 and 2 status undergoing ultrasound + DSA guided sclerotherapy for low flow venous malformations in head and neck region.
Exclusion criteria
Exclusion criteria: Known allergy to study drugs Significant cardiac, pulmonary, hepatic, renal, or neurologic disease Anticipated difficult airway Recent upper respiratory infection (within 2 weeks) or active respiratory compromise History of psychosis or developmental delay that precludes assessment of sedation/consent. Weight extremes where standard dosing is unsafe (per local protocol) Refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time to recovery between the Ketamine-remifentanil (KR) and Ketamine-propofol (KP) sedation regimens in pediatric patients undergoing sclerotherapy, measured as the time taken to achieve a Fast track recovery score more than 12.Timepoint: Every 5 mins in recovery room till FastTrack score is more than 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the depth of sedation achieved with KR versus KP using Ramsay sedation scale (RSS) at predefined intra-procedural intervals.Timepoint: Baseline Post induction 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes 30 minutes;To compare hemodynamic responses (heart rate, systolic & diastolic blood pressure)Timepoint: Baseline Post induction 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes 30 minutes;To evaluate total procedural duration, defined as the time from administration of the first sedative dose to arrival in the recovery areaTimepoint: From first sedative dose till transfer to recovery room;To evaluate respiratory safety, including the incidence of desaturation , apnea, & need for airway interventions between the two regimensTimepoint: Continuously during procedure from induction till transfer to recovery room In recovery room till discharge;To compare the requirement for supplemental sedative & rescue analgesia in both groups.Timepoint: Baseline Post induction 5 minutes 10 minutes 15 minutes 20 minutes 25 minutes 30 minutes;To assess operator(radiologist) satisfaction, including ease of performing sclerotherapy & patient immobility.Timepoint: Immediately after end of procedure;To compare incidence of adverse events such as nausea, vomiting, emergence reactions, hypersalivation, hypotension, bradycardia, or prolonged sedation.Timepoint: From induction till discharge from recovery room | — |
Countries
India
Contacts
Public ContactAnkita Paul Singh Kaushal
PGIMER Chandigarh
Outcome results
None listed