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Comparison of two drugs on Quality of Sedation in Paediatric Patients Undergoing Magnetic Resonance imaging.

Comparison of Effect of Dexmedetomidine with Ketofol and Ketofol alone on Quality of Sedation in Paediatric Patients Undergoing Magnetic Resonance Imaging(MRI):A Prospective Randomized Controlled Double Blind Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034211
Enrollment
132
Registered
2021-06-14
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: Z048- Encounter for examination and observation for other specified reasons

Interventions

Intervention1: INJ.DEXMETEDOMIDINE: inj.dexmed given as premedication dose-0.5mcg/kg/min over 10min via IV route. Control Intervention1: nil: nil

Sponsors

All India Institute of Medical Sciences Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. children belonging to American society of Anaesthesiologist (ASA) physical status I and II 2. Aged between 06 months to 10 years undergoing elective MRI on outpatient basis will be included in this study .

Exclusion criteria

Exclusion criteria: Parents refusal, patients with raised intracranial pressure, seizures, difficult airway, laryngomalacia, neck mass, congenital heart disease, gastroesophageal reflux disease, renal or hepatic dysfunction any psychiatric disorder, allergy or contraindication to study drug, patients requiring intubation, anticipated scan time less than 30 min & more than 1.5 hours; will be excluded from the study

Design outcomes

Primary

MeasureTime frame
To compare the quality of sedation between with and without dexmedetomidine before induction. Quality of sedation will be measured by subjective scale. 1. To compare the amount of rescue dose of propofol required for maintenance of sedation To compare total number of rescue doses of propofol required To compare duration of sedation To compare Recovery time To compare hemodynamic stability in children To compare incidence of adverse effects Timepoint: 18 months

Secondary

MeasureTime frame
1. To compare the amount of rescue dose of propofol required for maintenance of sedation To compare total number of rescue doses of propofol required To compare duration of sedation To compare Recovery time To compare hemodynamic stability in children To compare incidence of adverse effects Timepoint: 18 months

Countries

India

Contacts

Public ContactRakesh Kumar

AIIMS, Jodhpur

drrakeshspmc@gmail.com9460429221

Outcome results

None listed

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