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A clinical trial to study the effect of drug dexmedetomidine nebulization as premedication in children planned for MRI.

Effect of Dexmedetomidine nebulization as premedication in paediatric MRI: A randomized controlled study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085086
Enrollment
66
Registered
2025-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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: Intravenous Anaesthetic Drug: Intravenous Cannula inserted as per standard protocol Control Intervention1: Dexmedetomidine nebulization: Group D will receive Dexmedetomidine nebulizatio

Sponsors

Pt JNM medical College Raipur CG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric age group 2-10 years ASA grade I and II Scheduled for MRI under sedation MRI not more than 60 minute duration

Exclusion criteria

Exclusion criteria: 1. Not Nil By Mouth 2. Parents refusal 3. Congenital heart disease, upper respiratory tract infection 4. Patients on Antipsychotics, any sedative drugs. 5. Patients with altered sensorium and bradycardia

Design outcomes

Primary

MeasureTime frame
Compare total number of supplemental drugs required in dexmedetomidine group and control group.Timepoint: HR, SBP, DBP, SpO2 and sedation scale (SS-5) will be noted at the time of drug administration and thereafter, every 5 min for the first 30 min and then for every 10 min till discharge from recovery room.

Secondary

MeasureTime frame
1. To assess onset of sedation by sedation scale-5 (SS-5) 2. To assess parental Separation (PSAS) Score 3. To assess recovery assessment by modified Vancouver sedation recovery scale 4. To assess side effects and complication Hypotension, bradycardia, respiratory depression, nausea, vomiting and emergence agitationTimepoint: HR, SBP, DBP and SpO2, will be noted at the time of drug administration and thereafter, every 5 min for the first 30 min and then for every 10 min till discharge from recovery room.

Countries

India

Contacts

Public ContactDr Hemendra Chandra

Pt JNM medical College Raipur Chhattisgarh

rashminaik.2007@rediffmail.com7024558098

Outcome results

None listed

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