Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02299232
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-24
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine 3mcg/kg	Dexmedetomidine	dexmedetomidine 3 mcg/kg intranasal 50 minutes before MRI
dexmedetomidine 4mcg/kg	Dexmedetomidine	dexmedetomidine 4 mcg/kg intranasal 50 minutes before MRI

Primary Outcome Measures

Name	Time	Method
Ramsey Sedation Score	every 10 minutes for a two hours period	a score to determine sedation deepness