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Taking people in Finnország4. fázis

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

Key facts

Where
Kuopio, FinnországSee the 2 sites
Phase
4. fázis

Where in Finnország

  • Kuopio University HospitalKuopio, FinnországTaking people
  • Pohjois-Savon hyvinvointialueKuopio, FinnországTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Pohjois-Savon hyvinvointialue
Trial code
EU 2024-515530-33-00
Record updated
2024. szeptember 27.
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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.

EU CTIS 2024-515530-33-00