NCT04696445

Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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 (e.g. 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 and/or 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.

Conditions

• Opioid Use
• Side Effect of Drug
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Morphine & Oxycodone	Morphine and Oxycodone are used in daily practice as part of standard care. Morphine and Oxycodone will be acquired through the clinical pharmacy of St Antonius and administered according to the standard postoperative pain protocol.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-11-26
• Completion: 2021-11-26
• First posted: 2021-01-06
• Last updated: 2022-06-23

Locations

1 site across 1 country: Netherlands