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CompletedNCT04696445Updated Jun 23, 2022

Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

An observational study in Opioid Use, Side Effect of Drug and Postoperative Pain, sponsored by St. Antonius Hospital. Completed at 1 site in Netherlands. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.

Sponsored by St. Antonius Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
70 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Opioid Use
  • Side Effect of Drug
  • Postoperative Pain

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03

In context

Pain, Postoperative

5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 622 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥70 years undergoing elective cardiac surgery.

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing transcatheter aortic valve replacement or mitral valve repair
  • Contra-indication for morphine and/or oxycodone
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No

Interventions

  • DrugMorphine & Oxycodone

    Drug pages: 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.

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. Postoperative opioid consumption

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

    Time frame: Until three consecutive days after ICU discharge

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

1 site
  • St Antonius hospital
    Nieuwegein, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided — Plan to Share IPD: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Nov 2021, 13 months.

Of 347 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 13 months is close to that.

Counting every sponsor, half of 352 studies reached it within 14 months; a quarter within 6 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2020
First posted
Jan 6, 2021
StartActual
Oct 1, 2020
Primary completionActual
Nov 26, 2021
CompletionActual
Nov 26, 2021
Last update
Jun 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04696445
Lead sponsor
St. Antonius Hospital
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
dr. P. Noordzij (Principal Investigator, St. Antonius Hospital) — Principal investigator
First posted
Jan 6, 2021
Start date
Oct 1, 2020
Primary completion
Nov 26, 2021
Completion
Nov 26, 2021
Last update
Jun 23, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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