Myocardial Protection and Anesthetic Agents

Çukurova University

Status and phase: Completed; Phase 4

Conditions: Myocardial Ischemic Reperfusion Injury

Treatments: Drug: Sevoflurane; Drug: Remifentanil; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02405689

open heart surgery

Details and patient eligibility

About

The aim of this study was to investigate the myocardial protective effects of remifentanil and dexmedetomidine in cardiac surgery.

Full description

Fifty patients is included in this study. Routine monitorization included a 5-lead electrocardiogram (ECG), invasive arterial monitoring, pulse oximetry, capnography, temperature monitoring. Invasive arterial catheter were inserted under local anesthesia. Central venous catheter (jugular or subclavian) and esophageal heat probe were inserted after tracheal intubation.

Anesthesia induction was standardized in all patients and included 1 mg/kg propofol, 1 μg/kg fentanyl and 0.1 mg/kg vecuronium bromus to facilitate endotracheal intubation. The patients were divided into two groups by computer randomization method. Group R (n=25), remifentanil group and Group D (n=25) dexmedetomidine group. In the remifentanil group, anesthesia was maintained with 0.5-1.5% sevoflurane and 0.125-0.25 μg/kg/min remifentanil infusion. In the dexmedetomidine group anesthesia was maintained with 0.5-1.5% sevoflurane and 0.5 μg/kg dexmedetomidine loading dose during 10 minute and 0.3-0.9 μg/kg/min infusion.

Cardiopulmonary bypass (CPB) period was started after aort and venous cannulae were inserted. Mean arterial pressure, central venous pressure, venous oxygen saturation (SVO2) and arterial blood gase analysis were recorded. All blood samples include laktat, pyruvate, CKMB and Troponin-T were taken via the coronary sinus catheter at specific time intervals (precardiopulmonary bypass, 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass).

Cardiopulmonary bypass time, aortic cross clamping time, the need of defibrillation/intraaortic balloon pumping (IABP)/extracorporeal membrane oxygenator (ECMO), urine output, positive inotropic agents requirement were recorded. At the end of surgery, the patients were transferred intensive care unit intubated and full monitorized.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled to open heart surgery
• American Society of Anesthesiologists (ASA) physical status of II-III

Exclusion criteria

• Emergency surgery, prior cardiac surgery, ejection fraction < 50%, restrictive or obstructive pulmonary disease, preoperative mechanical ventilation, intra-aortic balloon pump, chronic liver and renal failure.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

remifentanil

Active Comparator group

Description:

In the remifentanil group, anesthesia was maintained with 0.5-1.5% sevoflurane and 0.125-0.25 μg/kg/min remifentanil infusion during surgery

Treatment:

Drug: Remifentanil

Drug: Sevoflurane

dexmedetomidine

Active Comparator group

Description:

In the dexmedetomidine group anesthesia was maintained with 0.5-1.5% sevoflurane and 0.5 μg/kg dexmedetomidine loading dose during 10 minute and then 0.3-0.9 μg/kg/min infusion.

Treatment:

Drug: Dexmedetomidine

Drug: Sevoflurane