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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001462-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| M3G concentration in blood over time | 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 | 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 | 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 | Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling | Until three consecutive days after ICU discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe) | NRS as pain measurement scale, reported by nurse in standard care, for pharmacodynamic modelling | Until three consecutive days after ICU discharge |
| Postoperative opioid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes 20 patients ≥70 years undergoing elective cardiac surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Antonius hospital | Nieuwegein | Netherlands |
Plan to Share IPD: Undecided
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D010098 | Oxycodone |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling
| 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 | 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 | 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 | 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 | Until three consecutive days after ICU discharge |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003061 | Codeine |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |