* 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.
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.
Study Type
OBSERVATIONAL
Enrollment
34
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.
St Antonius hospital
Nieuwegein, Netherlands
M3G concentration in blood over time
Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling
Time frame: Until three consecutive days after ICU discharge
M6G concentration in blood over time
Analysis of serum concentrations of M6G, metabolite of morphine, for pharmacokinetic modelling
Time frame: Until three consecutive days after ICU discharge
Noroxycodone concentration in blood over time
Analysis of serum concentrations of Noroxycodone, metabolite of oxycodone, for pharmacokinetic modelling
Time frame: Until three consecutive days after ICU discharge
Oxymorphone concentration in blood over time
Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling
Time frame: Until three consecutive days after ICU discharge
Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)
NRS as pain measurement scale, reported by nurse in standard care, for pharmacodynamic modelling
Time frame: Until three consecutive days after ICU discharge
Postoperative opioid consumption
Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling
Time frame: Until three consecutive days after ICU discharge
Side effects of opioids
Side effects of opioids (pruritis, vomiting, constipation, nausea), dichotomous (yes/no) each day by nurse/researcher, for pharmacodynamic modelling
Time frame: Until three consecutive days after ICU discharge
Vital sign observation: bloodpressure (in mmHg) by nurse
Systolic and diastolic bloodpressure (SBP, DBP), reported by nurse in standard care for pharmacodynamic modelling
Time frame: Until three consecutive days after ICU discharge
Vital sign observation: heartrate (in beats/minute) by nurse
Heartrate (HR) reported by nurse in standard care for pharmacodynamic modelling
Time frame: Until three consecutive days after ICU discharge
Vital sign observation: saturation (in %) by nurse
Saturation (SpO2), reported by nurse in standard care for pharmacodynamic modelling
Time frame: Until three consecutive days after ICU discharge
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