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Comparison of three different drug regimens for sedation in children undergoing MRI

Comparison of three different drug regimens for sedation in children undergoing Magnetic resonance imaging: A prospective randomized study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022949
Enrollment
51
Registered
2020-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B- Imaging Health Condition 2: 4- Measurement and Monitoring

Interventions

Control Intervention1: Propofol: dose: 1mg/kg route of administration: Intravenous, frequency: as infusion during the MRI procedure. duration of therapy: during the mri procedure only. Control Interv

Sponsors

Dr Rohit
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists (ASA) status 1 and 2, Aged 1 to 10 years, Scheduled for elective MRI.

Exclusion criteria

Exclusion criteria: Significant cardiovascular or pulmonary pathology, Patients with any allergy or contraindication to study drugs, Anatomical anomaly or suspected difficulty of the airway.

Design outcomes

Primary

MeasureTime frame
Time to discharge from recovery room.Timepoint: at baseline, after completion of imaging procedure.

Secondary

MeasureTime frame
Incidence of adverse events namely postoperative nausea and vomiting (PONV), hemodynamics, respiratory events. Timepoint: during scan and recovery;Incidence of emergence delirium based on the pediatric anesthesia emergence delirium (PAED) scaleTimepoint: during recovery from sedation;Parental satisfaction score about Anaesthesia and recovery. Timepoint: during scan and recovery;Quality of Induction, Quality of sedation, quality of MRI Timepoint: during the scan;Recovery/Awakening timeTimepoint: Time to recovery from sedation to RSS 2 after stopping the drug infusion;Scan duration. Timepoint: total time taken to complete MRI;Time to Induction of sleep Timepoint: time to achieve RSS of 4-5 after the loading dose

Countries

India

Contacts

Public ContactRohit

Maulana azad medical college and Lok Nayak Hospital

kirtinath@gmail.com9968604215

Outcome results

None listed

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