Opioid UseNCT04696445
Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery
An observational study of Opioid Use and Side Effect of Drug, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Opioid Use, Side Effect of Drug, Postoperative Pain
- What is being tested?
- Morphine & Oxycodone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2020to 26 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population includes 20 patients ≥70 years undergoing elective cardiac surgery.
Who may be able to join
- ≥70 years undergoing elective cardiac surgery.
Who cannot join
- Patients undergoing transcatheter aortic valve replacement or mitral valve repair
- Contra-indication for morphine and/or oxycodone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Opioid Use, Side Effect of Drug, Postoperative Pain
- Being tested
- Morphine & Oxycodone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine & OxycodoneDrug
Also called Morphine HCl CF 10mg/mL solution for injection / infusion, OxycodoneHCl G.L. tablet 5/10mg., OxycodoneHCl Retard Lannacher 5/10/20 mg.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
M3G concentration in blood over time
Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling
Measured: 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
Measured: 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
Measured: 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
Measured: Until three consecutive days after ICU discharge
Secondary outcomes (6)
Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)
NRS as pain measurement scale, reported by nurse in standard care, for pharmacodynamic modelling
Measured: Until three consecutive days after ICU discharge
Postoperative opioid consumption
Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Until three consecutive days after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Oct 2020
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. P. Noordzij, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696445
- Sponsor's protocol ID
- NL71713.100.20
- Other IDs
- 2020-001462-10
- Status last verified
- Jun 2022
- First submitted
- 22 Oct 2020
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to Share IPD: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II
- ClinicalTrials.gov ID
- NCT04696445
- Acronym / sponsor ID
- NL71713.100.20
- Conditions
- Opioid Use, Side Effect of Drug, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population includes 20 patients ≥70 years undergoing elective cardiac surgery.
Key inclusion criteria (1 listed)
- ≥70 years undergoing elective cardiac surgery.
Key exclusion criteria (2 listed)
- Patients undergoing transcatheter aortic valve replacement or mitral valve repair
- Contra-indication for morphine and/or oxycodone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine & OxycodoneAlso: Morphine HCl CF 10mg/mL solution for injection / infusion, OxycodoneHCl G.L. tablet 5/10mg., OxycodoneHCl Retard Lannacher 5/10/20 mg.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. | Drug | – |
Primary outcome
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
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
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
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
6 secondary outcomes
Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)
Time frame: Until three consecutive days after ICU discharge
Postoperative opioid consumption
Time frame: Until three consecutive days after ICU discharge
Side effects of opioids
Time frame: Until three consecutive days after ICU discharge
Vital sign observation: bloodpressure (in mmHg) by nurse
Time frame: 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
Vital sign observation: saturation (in %) by nurse
Time frame: Until three consecutive days after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: Undecided. Plan to Share IPD: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Side Effect of Drug, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M3G concentration in blood over time (time frame: Until three consecutive days after ICU discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.