Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 1-8 years, of either sex 2. ASA PS I-III 3. Children scheduled for elective MRI
Exclusion criteria
Exclusion criteria: 1 Parents / Guardians refusal to consent. 2. Known allergy to study drug. 3. Presence of Congenital Heart disease. 4. Raised Intracranial Tension / Refractory Seizures / Altered sensorium. 5. Renal / Hepatic Dysfunction. 6. Anticipated Difficult Airway / Craniofacial Anomaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of sedation during MRI, rated by the anaesthesiologist as Excellent, Good, or Poor based on patient movement and scan interruptions.Timepoint: Immediately after completion of MRI scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of MRI images, evaluated by a blinded radiologist using a 3-point image quality scoring system-excellent, good, poor.Timepoint: Immediately after completion of MRI scan.;Onset of sedation, defined by the time interval between the administration of the final sedative bolus -ketamine or propofol and the achievement of Ramsay Sedation Score of 5, indicating readiness to begin MRI scanning.Timepoint: From administration of final sedative bolus to achievement of RSS score 5;Number of Rescue Boluses -the total number of additional bolus doses given after the initiation of sedation to maintain RSS 5Timepoint: During the MRI procedure.;Total Ketamine Dose used: The cumulative dose of ketamine administered during the procedure, including induction and any supplemental boluses.Timepoint: Cumulative dose recorded at end of MRI procedure.;Incidence of adverse events including desaturation defined as oxygen saturation less than 94 percent, apnea, and hemodynamic instability defined as a decrease in heart rate or mean arterial pressure by more than 20 percent from baseline.Timepoint: From initiation of sedation until complete recovery.;Recovery Time defined as the time interval from the cessation of the sedative infusion to the achievement of a Ramsay Sedation Score of 2, indicating the child is awake, cooperative, and orientedTimepoint: From end of MRI procedure until recovery;Sedation Failure, defined as the inability to achieve RSS 5 initially or need to switch to another sedation technique. Timepoint: During the induction and MRI procedure | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Rishikesh