Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT02557867
Status:
UNKNOWN
Last Update Posted:
2016-10-12
First Post:
2015-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Obesity in Dexmedetomidine Metabolic Clearance
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Study Overview
Official Title:
The Effect of Obesity in Dexmedetomidine Metabolic Clearance
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study is to study the effect of obesity in dexmedetomidine pharmacokinetics and pharmacodynamic profile.
Detailed Description:
The investigators expect to find an inverse correlation between the amount of fat mass and liver blood flow or with the enzymatic metabolic capacity. Results will be based on a population pharmacokinetic modeling analysis performed in NONMEM program. The investigators will first account for the effect of different measured size scalars on volumes and clearances and then they will search for plausible covariates (liver blood flow, enzymatic capacity, degree of hepatic steatosis, etc) on dexmedetomidine metabolic clearance. A pharmacokinetic model capable of characterizing clearance changes in the obese using more plausible biological covariates will be tried to be defined.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1150197 | OTHER_GRANT | FONDECYT | View |