PROPOFOL for Valvular heart disease | Coronary heart disease | Aortic disorder

Inclusion criteria

• {"criterion_text":"-elective cardiac surgery with cardiopulmonary bypass"}
• {"criterion_text":"-age ≥18 and ≤90 years"}
• {"criterion_text":"-informed consent"}

Exclusion criteria

• {"criterion_text":"-preoperative use of benzodiazepines (premedication or chronic use)"}
• {"criterion_text":"-heart transplantation"}
• {"criterion_text":"-left ventricular assist device implantation"}
• {"criterion_text":"-cardioplegia with Custodiol® solution"}
• {"criterion_text":"-contraindications to study drugs"}
• {"criterion_text":"-pregnant women"}
• {"criterion_text":"-preoperative chronic use of opioids or chronic pain"}
• {"criterion_text":"-emergency surgery"}
• {"criterion_text":"-reoperations"}
• {"criterion_text":"-preoperative hemodynamic instability requiring catecholamines"}
• {"criterion_text":"-chronic severe renal insufficiency (≥G4 according to KDIGO 2012)"}
• {"criterion_text":"-liver dysfunction with Child-Pugh Class B or C"}
• {"criterion_text":"-planned hypothermic circulatory arrest"}
• {"criterion_text":"-planned hypothermia on cardiopulmonary bypass <35°C"}

Primary endpoints

• {"endpoint_text":"-The primary endpoint is the median prediction error (MDPE) for propofol and remifentanil concentrations.","definition_or_measurement_approach":"MDPE will be calculated to assess performance of the Eleveld PK model during cardiac anesthesia; an MDPE between -20% and +20% is considered acceptable."}

Secondary endpoints

• {"endpoint_text":"-The agreement between measured and predicted propofol and remifentanil concentrations will be evaluated using Bland-Altman analysis.","definition_or_measurement_approach":"Agreement evaluated using Bland-Altman analysis."}
• {"endpoint_text":"-The median absolute prediction error (MDAPE) will be calculated for propofol and remifentanil. An MDAPE <30% is considered clinically acceptable","definition_or_measurement_approach":"Calculate MDAPE; threshold <30% considered acceptable."}
• {"endpoint_text":"-The intraoperative area under the curve (AUC) for estimated and measured propofol and remifentanil concentrations will be compared. A difference of 20% will be considered clinically acceptable.","definition_or_measurement_approach":"Compare intraoperative AUCs for estimated vs measured concentrations; difference of 20% considered acceptable."}
• {"endpoint_text":"-The BIS value at each sampling time point will be recorded. BIS values will be plotted against CE of propofol and SEVET to describe the distribution of BIS values at each CE and SEVET","definition_or_measurement_approach":"Record BIS at each sampling time point and plot against effect-site concentrations (CE) of propofol and end-tidal sevoflurane (SEVET)."}
• {"endpoint_text":"-BIS, SEF, SR and ST values will be recorded continuously. Descriptive statistics will be used to describe the percentage of time the BIS, SEF, SR and ST values were within the target range throughout anesthesia.","definition_or_measurement_approach":"Continuous recording of BIS, SEF, SR, ST; use descriptive statistics to report percentage of time within target ranges."}
• {"endpoint_text":"-Descriptive statistics will be used to report the range of NOL values at each sampling time point. NOL values will be plotted against CE of remifentanil to describe the distribution of NOL values at each CE of remifentanil.","definition_or_measurement_approach":"Descriptive statistics for NOL values at each sampling point; plot versus remifentanil CE."}
• {"endpoint_text":"-Descriptive statistics will be used to report the range of PPI values at each sampling time point. PPI values will be plotted against CE of remifentanil to describe the distribution of PPI values at each CE of remifentanil.","definition_or_measurement_approach":"Descriptive statistics for PPI values at each sampling point; plot versus remifentanil CE."}
• {"endpoint_text":"-The agreement between analgesic depth provided by NOL® and PPI will be evaluated using Bland-Altman analysis.","definition_or_measurement_approach":"Agreement between NOL and PPI evaluated using Bland-Altman analysis."}
• {"endpoint_text":"-After stratification for gender, MDPE and MDAPE will be compared between male and female patients (Mann-Whitney-U test).","definition_or_measurement_approach":"After gender stratification, compare MDPE and MDAPE between sexes using Mann-Whitney U test."}

Austria

Earliest CTIS Part Ii Submission Date

25-03-2024

Latest Decision Or Authorization Date

29-04-2024

Processing Time Days

35

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Medical University of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria