Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation (DEX)

Sisli Hamidiye Etfal Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02299232

295/25.02.2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

dexmedetomidine 3mcg/kg

Active Comparator group

Description:

dexmedetomidine 3 mcg/kg intranasal 50 minutes before MRI

Treatment:

Drug: Dexmedetomidine

dexmedetomidine 4mcg/kg

Active Comparator group

Description:

dexmedetomidine 4 mcg/kg intranasal 50 minutes before MRI

Treatment:

Drug: Dexmedetomidine