Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-01 @ 6:11 PM
Study NCT ID:
NCT00909935
Status:
TERMINATED
Last Update Posted:
2017-06-12
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pharmacokinetics of Dexmedetomidine in Children
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
The Pharmacokinetics of Dexmedetomidine in Children
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to enroll enough patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to identify the plasma concentrations which are required to achieve adequate sedation, using a Ramsay Sedation Scale. As an alpha 2 agonist, dexmedetomidine can elicit hemodynamic changes, fluctuations in blood pressure and heart rate. This study will attempt to determine whether these changes can be predicted by plasma concentrations.
Detailed Description:
Dexmedetomidine, an alpha2 agonist is currently the standard of care for sedation for diagnostic (MRI, CT and Nuclear Medicine) radiological studies at Boston Children's Hospital. Although it is FDA approved for sedation, its pharmacokinetics in children has not been carefully studied with prospective studies. The plasma concentration of dexmedetomidine necessary to achieve and maintain adequate sedation for motionless conditions for a MRI study has not been determined which is the purpose of this study.
Study Oversight
Has Oversight DMC:
True
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?: