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Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02299232
Acronym
DEX
Enrollment
60
Registered
2014-11-24
Start date
2014-02-28
Completion date
2014-04-30
Last updated
2017-10-25

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

Conditions

Anesthesia

Keywords

dexmedetomidine, sedation, MRI

Brief summary

Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

Detailed description

OBJECTIVES OF STUDY Anesthetic agents used for MRI in paediatrics should have few adverse effects, allow fast induction and recovery. The administration route is also important and should be minimally invasive. In this study the investigators aimed to compare two different doses of intranasal dexmedetomidine applied to children for MRI sedation. MATERIALS AND METHODS Sixty patients aged between 1-10 years, ASA I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes HR, SpO2 and RSS were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

Interventions

DRUGDexmedetomidine

Drug: dexmedetomidine 100 mcg/mL was applied in 3 mcg/kg and 4 mcg/kg doses in 1 mL preperates, 0.5 mL for each nostril

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* MRI * ASA I-II

Exclusion criteria

* hepatic and renal failure * difficult airway * nasal deformity * anaphylaxis to dexmedetomidine * neurologic disease * metabolic disorders * electrolyte imbalance * dehydration * malnutrition

Design outcomes

Primary

MeasureTime frameDescription
Ramsey Sedation Scoreevery 10 minutes for a two hours perioda score to determine sedation deepness

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026