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Pharmacokinetics of morphine and oxycodone in frail elderly undergoing cardiac surgery

Pharmacokinetics of morphine and oxycodone in frail elderly undergoing cardiac surgery - AWARE II

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55041
Enrollment
40
Registered
2020-08-05
Start date
2020-10-06
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CABG cardiothoracic surgery

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Adult patients *70 years undergoing elective cardiac surgery 2. Frailty, defined by the presence of at least two of the following characteristics: - Impaired gait speed or hand grip strength - Risk for malnutrition - Impaired cognition - Dependent living - Impaired physical functioning - Polypharmacy - Impaired health related quality of life

Exclusion criteria

Exclusion criteria: Patients undergoing emergency cardiac surgery Patients undergoing transcatheter aortic valve replacement or mitral valve repair. Contraindication for morphine and/or oxycodone No informed consent

Design outcomes

Primary

MeasureTime frame
Primary endpoints of this study are the pharmacokinetic parameters of morphine, oxycodone and metabolites in blood in frail patients. Pharmacokinetic parameters are clearance , volume of the central compartment, volume of the peripheral compartment, volume of distribution

Secondary

MeasureTime frame
* Pain according to Numeric Rating Scale (NRS) * Postoperative opioid consumption in the first 5 postoperative days * Vital signs by continuous monitoring (SpO2, respiratory rate, blood pressure) * Side effects of opioids (nausea, vomiting, pruritus, constipation) * Delirium according to delirium observation screening (DOS) * Sedation according to sedation observation scale

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)