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NCT Number: NCT04696445

Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

* 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.

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Key information

Conditions

Opioid Use Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Side Effect of Drug Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Antonius hospital

Nieuwegein, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine & Oxycodone

Drug

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.

Other names: Morphine HCl CF 10mg/mL solution for injection / infusion, OxycodoneHCl G.L. tablet 5/10mg., OxycodoneHCl Retard Lannacher 5/10/20 mg.

Primary outcomes

  1. M3G concentration in blood over time

    Time frame: Until three consecutive days after ICU discharge

    Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling

  2. M6G concentration in blood over time

    Time frame: Until three consecutive days after ICU discharge

    Analysis of serum concentrations of M6G, metabolite of morphine, for pharmacokinetic modelling

  3. Noroxycodone concentration in blood over time

    Time frame: Until three consecutive days after ICU discharge

    Analysis of serum concentrations of Noroxycodone, metabolite of oxycodone, for pharmacokinetic modelling

  4. Oxymorphone concentration in blood over time

    Time frame: Until three consecutive days after ICU discharge

    Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling

Secondary outcomes

  1. Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)

    Time frame: Until three consecutive days after ICU discharge

    NRS as pain measurement scale, reported by nurse in standard care, for pharmacodynamic modelling

  2. Postoperative opioid consumption

    Time frame: Until three consecutive days after ICU discharge

    Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling

  3. Side effects of opioids

    Time frame: Until three consecutive days after ICU discharge

    Side effects of opioids (pruritis, vomiting, constipation, nausea), dichotomous (yes/no) each day by nurse/researcher, for pharmacodynamic modelling

  4. Vital sign observation: bloodpressure (in mmHg) by nurse

    Time frame: Until three consecutive days after ICU discharge

    Systolic and diastolic bloodpressure (SBP, DBP), reported by nurse in standard care for pharmacodynamic modelling

  5. Vital sign observation: heartrate (in beats/minute) by nurse

    Time frame: Until three consecutive days after ICU discharge

    Heartrate (HR) reported by nurse in standard care for pharmacodynamic modelling

  6. Vital sign observation: saturation (in %) by nurse

    Time frame: Until three consecutive days after ICU discharge

    Saturation (SpO2), reported by nurse in standard care for pharmacodynamic modelling

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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