Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696445
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2020-10-22
Brief Title:
Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
Single centre observational cohort study
20 older patients undergoing cardiac surgery who receive standard of care pain treatment
Postoperative ICU blood sampling to determine morphine and metabolite M3G M6G noroxycodone and oxymorphone pharmacokinetics
After ICU discharge on general ward blood sampling to determine morphine oxycodone and metabolite M3G M6G noroxycodone and oxymorphone pharmacokinetics
During study monitoring of pain scores total opioid consumption side effects eg nausea vomiting pruritus sedation and delirium scores
20 older patients undergoing cardiac surgery who receive standard of care pain treatment
Postoperative ICU blood sampling to determine morphine and metabolite M3G M6G noroxycodone and oxymorphone pharmacokinetics
After ICU discharge on general ward blood sampling to determine morphine oxycodone and metabolite M3G M6G noroxycodone and oxymorphone pharmacokinetics
During study monitoring of pain scores total opioid consumption side effects eg nausea vomiting pruritus sedation and delirium scores
Detailed Description:
Postoperative pain after cardiac surgery in elderly patients is common and leads to postoperative complications Opioids play an important role in treatment of postoperative pain after cardiac surgery In frail elderly after cardiac surgery however dosing schemes for opioids are still unknown potentially leading to inadequate treatment of pain andor safety issues
Single center observational cohort study
The study population includes frail patients 70 years undergoing elective cardiac surgery
Primary endpoints of this study is the concentration of morphine oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling
Secondary endpoints of this study are the pharmacodynamic parameters of morphine oxycodone and metabolites M3G M6G noroxycodone and oxymorphone in blood in frail patients such as pain scores postoperative opioid consumption vital signs side effects of opioids and the influence of covariates such as frailty serum creatinine Glomerular Filtration Rate GFR on the pharmacokinetics and pharmacodynamics of morphine and oxycodone
Single center observational cohort study
The study population includes frail patients 70 years undergoing elective cardiac surgery
Primary endpoints of this study is the concentration of morphine oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling
Secondary endpoints of this study are the pharmacodynamic parameters of morphine oxycodone and metabolites M3G M6G noroxycodone and oxymorphone in blood in frail patients such as pain scores postoperative opioid consumption vital signs side effects of opioids and the influence of covariates such as frailty serum creatinine Glomerular Filtration Rate GFR on the pharmacokinetics and pharmacodynamics of morphine and oxycodone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001462-10 | EUDRACT_NUMBER | None | None |