Oxycodone hydrochloride for Coronary artery disease | Aortic valve disease | Mitral valve disease | Tricuspid valve disease

Inclusion criteria

• {"criterion_text":"- Age > 18 years"}
• {"criterion_text":"- Patient has indication for open heart surgery using cardiopulmonary bypass with conventional extracorporeal perfusion or miniperfusion method."}
• {"criterion_text":"- The patient understands the study protocol"}
• {"criterion_text":"- The patient gives informed consent"}

Exclusion criteria

• {"criterion_text":"- Age < 18 years"}
• {"criterion_text":"- BMI over 35 kg/m2"}
• {"criterion_text":"- Sensitivity to used drugs or their excipients."}
• {"criterion_text":"- Hepatic (MELD-score 15 or over) or renal insufficiency (GFR less than 30 mL/min)"}
• {"criterion_text":"- Difficult respiratory disease (FEV1 less than 1,2 L) or need of supplementary oxygen"}
• {"criterion_text":"- Any severity of recognized sleep apnoea (need of nasal CPAP) or disease of central nervous respiratory centre"}
• {"criterion_text":"- No informed consent"}
• {"criterion_text":"- Other reason, the researcher evaluates that patient is not eligible for the study."}

Primary endpoints

• {"endpoint_text":"- Nightly pulse oximetry desaturations: amount, depth, and time of recovery heir duration and respiratory rate. The connection of these changes to use of oxycodone PCA use.","definition_or_measurement_approach":"Measured by nightly pulse oximetry recording of peripheral oxygen saturation (SpO2): count, depth and duration of desaturations, and respiratory rate; analysis of connection to oxycodone PCA use and plasma concentrations as described in main objective."}

Secondary endpoints

• {"endpoint_text":"- Pain after cardiac surgery, morbidity, anxiety and depression, resilience, life satisfaction and heath related quality of life","definition_or_measurement_approach":"Patient-reported outcomes and clinical morbidity measures; specific timepoints include 30 days, 6 weeks, 3, 6 and 12 months (as per secondary objectives)."}
• {"endpoint_text":"- Pain assessment daily with NRS at the hospital","definition_or_measurement_approach":"Daily Numeric Rating Scale (NRS) assessments performed during hospital stay."}
• {"endpoint_text":"- Surgical complications with Clavien-Dindo classification","definition_or_measurement_approach":"Complications graded using the Clavien-Dindo classification system."}
• {"endpoint_text":"- Pain outside hospital with Brief Pain Inventory (BPI)","definition_or_measurement_approach":"Pain assessed after discharge using the Brief Pain Inventory (BPI) questionnaire."}

Finland

Earliest CTIS Part Ii Submission Date

19-07-2024

Latest Decision Or Authorization Date

27-09-2024

Processing Time Days

70

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

Pohjois-Savon hyvinvointialue

Organisation Type

Patient organisation/association

Country Of Registered Address

Finland