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

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.

Conditions

• Heart Disease

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.

Sponsors & Collaborators

• AHEPA University Hospital

  lead OTHER

Principal Investigators

• Vasileios Kamperidis, Assistant Professor · 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

• Despoina Sarridou, Associate Professor · Department of Anesthesiology, AHEPA University Hospital, Aristotle University of Thessaloniki

• Helena Argiriadou, Professor · Department of Anesthesiology and Intensive Care, AHEPA University Hospital, Aristotle University of Thessaloniki

• Antonios Ziakas, Professor · 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

• Christos Mantzios, Cardiology Resident, MD, MSc · 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-19

Primary Completion

2026-11-30

Completion

2027-11-30

Countries

• Greece

Study Locations