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Comparing two types of sleep medicines to see which keeps children safely asleep during MRI.

COMPARISON OF KETAMINE-DEXMEDETOMIDINE VERSUS KETAMINE-PROPOFOL FOR QUALITY OF SEDATION AND RECOVERY IN PAEDIATRIC PATIENTS UNDERGOING MAGNETIC RESONANCE IMAGING: A RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099538
Enrollment
116
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine Ketamine group: Dexmedetomidine 0.5 g/kg will be administered as an intravenous bolus over 10 minutes, followed by a continuous infusion at 0.3 g/kg/h. Ketamine 0.5 mg/

Sponsors

AIIMS Rishikesh, Uttarakhand
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Mridul Dhar

All India Institute of Medical Sciences, Rishikesh

mriduldhar87@gmail.com9717778374

Outcome results

None listed

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