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

RecruitingNA

Sponsor: AHEPA University Hospital

Conditions: Heart Disease

Interventions: BIS-guided anesthesia: BIS 45-55, BIS-guided anesthesia: BIS 30-35

Countries: Greece

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 study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes. Participants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Thessaloniki, Greece