2024-515530-33-00RecruitingPhase 4
PCA-oxycodone after cardiac surgery; respiratory effects, and short and long term outcome
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main study objective is to evaluate the respiratory effects of oxycodone PCA using measurement and analysis of patients’ peripheral oxygen saturation (SpO2), possible desaturations and their duration and respiratory rate. The connection of these changes to use of oxycodone PCA, i.e. amount of drug used, plasma concentrations of oxycodone and its metabolites are evaluated.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- 25 Mar 2025
- Lead sponsor
- Pohjois-Savon hyvinvointialue
- Diseases
- Coronary artery disease
- EU CT number
- 2024-515530-33-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- Age < 18 years • BMI over 35 kg/m2 • Sensitivity to used drugs or their excipients. • Hepatic (MELD-score 15 or over) or renal insufficiency (GFR less than 30 mL/min) • Difficult respiratory disease (FEV1 less than 1,2 L) or need of supplementary oxygen • Any severity of recognized sleep apnoea (need of nasal CPAP) or disease of central nervous respiratory centre • No informed consent • Other reason, the researcher evaluates that patient is not eligible for the study.
Who the study is looking for
- Age > 18 years • Patient has indication for open heart surgery using cardiopulmonary bypass with conventional extracorporeal perfusion or miniperfusion method. • The patient understands the study protocol • The patient gives informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kuopio University Hospital | Kuopio | Finland | Recruiting |
| Pohjois-Savon hyvinvointialue | Kuopio | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.