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Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery

RecruitingNAAges 18 Years - anyAllAHEPA University Hospital
NCT07770269 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes. Participants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded. The primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older, irrespective of sex. * Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery). * Anticipated adequate acoustic window for transthoracic echocardiography. * Provision of written informed consent. Exclusion Criteria: * \- Emergency or unscheduled cardiac surgery. * Cardiac surgery without cardiopulmonary bypass (off-pump surgery). * Refusal or inability to provide written informed consent.
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What it tests

  • BIS-guided anesthesia: BIS 45-55
  • BIS-guided anesthesia: BIS 30-35
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Where

1 site
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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