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RECRUITING
NCT07770269
NA

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

Sponsor: AHEPA University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Multifactorial Assessment of Cardiac Function Through Deformation Imaging, Hemodynamic Parameters, and Anesthesia-related Variables in Patients Undergoing Cardiac Surgery: The SHAPE Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-01-19

Completion Date

2027-11

Last Updated

2026-08-19

Healthy Volunteers

No

Conditions

Interventions

OTHER

BIS-guided anesthesia: BIS 45-55

Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.

OTHER

BIS-guided anesthesia: BIS 30-35

Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.

Locations (1)

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece