Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

June 16, 2022 updated by: dr. P. Noordzij, St. Antonius Hospital

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands
        • St Antonius hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population includes 20 patients ≥70 years undergoing elective cardiac surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until three consecutive days after ICU discharge
Postoperative opioid consumption
Time Frame: Until three consecutive days after ICU discharge
Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge
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
Until three consecutive days after ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ACTUAL)

November 26, 2021

Study Completion (ACTUAL)

November 26, 2021

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (ACTUAL)

January 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL71713.100.20
  • 2020-001462-10 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plan to Share IPD: Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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