Clinical trial NCT04696445: Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery
Official title: Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Side Effect of Drug
Postoperative Pain
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2021-01-06
Enrollment: 34
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes 20 patients ≥70 years undergoing elective cardiac surgery.

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 (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.

Eligibility criteria: Inclusion Criteria:

* ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

* Patients undergoing transcatheter aortic valve replacement or mitral valve repair
* Contra-indication for morphine and/or oxycodone

Primary outcomes:
measure: M3G concentration in blood over time
timeFrame: Until three consecutive days after ICU discharge
measure: M6G concentration in blood over time
timeFrame: Until three consecutive days after ICU discharge
measure: Noroxycodone concentration in blood over time
timeFrame: Until three consecutive days after ICU discharge
measure: Oxymorphone concentration in blood over time
timeFrame: Until three consecutive days after ICU discharge
Secondary outcomes:
measure: Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)
timeFrame: Until three consecutive days after ICU discharge
measure: Postoperative opioid consumption
timeFrame: Until three consecutive days after ICU discharge
measure: Side effects of opioids
timeFrame: Until three consecutive days after ICU discharge
measure: Vital sign observation: bloodpressure (in mmHg) by nurse
timeFrame: Until three consecutive days after ICU discharge
measure: Vital sign observation: heartrate (in beats/minute) by nurse
timeFrame: Until three consecutive days after ICU discharge
measure: Vital sign observation: saturation (in %) by nurse
timeFrame: Until three consecutive days after ICU discharge
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
Study officials:
References: