Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02299232
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2014-11-05
Brief Title:
Dexmedetomidine in Children for Magnetic Resonance Imaging MRI Sedation
Sponsor:
Sisli Hamidiye Etfal Training and Research Hospital
Organization:
Sisli Hamidiye Etfal Training and Research Hospital
Study Overview
Official Title:
Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging MRI Sedation
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEX
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 mcgkg Group 2 received 4 mcgkg 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 mcgkg Group 2 received 4 mcgkg 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
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 mcgkg Group 2 received 4 mcgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None