Authorised Therapeutic use (Phase IV) coronary artery disease Aortic valve disease Mitral valve disease Tricuspidal valve disease or combination of the above

PCA-oxycodone after cardiac surgery; respiratory effects, and short and long term outcome

EU CTIS ID: 2024-515530-33-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • • 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

You likely can't join if

  • • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.