Pharmacokinetics of morphine and oxycodone in frail elderly undergoing cardiac surgery
Phase 4
Completed
- Conditions
- CABGcardiothoracic surgery10007593
- Registration Number
- NL-OMON55041
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
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
Patients undergoing emergency cardiac surgery
Patients undergoing transcatheter aortic valve replacement or mitral valve
repair.
Contraindication for morphine and/or oxycodone
No informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints of this study are the pharmacokinetic parameters of morphine,<br /><br>oxycodone and metabolites in blood in frail patients. Pharmacokinetic<br /><br>parameters are clearance , volume of the central compartment, volume of the<br /><br>peripheral compartment, volume of distribution</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Pain according to Numeric Rating Scale (NRS)<br /><br>* Postoperative opioid consumption in the first 5 postoperative days<br /><br>* Vital signs by continuous monitoring (SpO2, respiratory rate, blood pressure)<br /><br>* Side effects of opioids (nausea, vomiting, pruritus, constipation)<br /><br>* Delirium according to delirium observation screening (DOS)<br /><br>* Sedation according to sedation observation scale </p><br>