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Evaluation of the Eleveld Pharmacokinetic Model for Propofol and Remifentanil in Cardiac Anesthesia with Cardiopulmonary Bypass
EU CTIS ID: 2023-507808-31-00
What this study is testing
The primary objective is to evaluate if there is a clinically significant difference between the measured and predicted concentrations during TCI of propofol and remifentanil using the Eleveld PK model. The median prediction error (MDPE) will be calculated to assess the performance of the Eleveld PK model during cardiac anesthesia. An MDPE between -20% and +20% is considered acceptable.
- 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
- elective cardiac surgery with cardiopulmonary bypass
- age ≥18 and ≤90 years
- informed consent
You likely can't join if
- preoperative use of benzodiazepines (premedication or chronic use)
- heart transplantation
- left ventricular assist device implantation
- cardioplegia with Custodiol® solution
- contraindications to study drugs
- pregnant women
See the full eligibility criteria
- elective cardiac surgery with cardiopulmonary bypass
- age ≥18 and ≤90 years
- informed consent
- preoperative use of benzodiazepines (premedication or chronic use)
- heart transplantation
- left ventricular assist device implantation
- cardioplegia with Custodiol® solution
- contraindications to study drugs
- pregnant women
- preoperative chronic use of opioids or chronic pain
- emergency surgery
- reoperations
- preoperative hemodynamic instability requiring catecholamines
- chronic severe renal insufficiency (≥G4 according to KDIGO 2012)
- liver dysfunction with Child-Pugh Class B or C
- planned hypothermic circulatory arrest
- planned hypothermia on cardiopulmonary bypass <35°C
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, 18-64 years, 65+ 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.