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临床试验/NCT02405689
NCT02405689已完成4 期

The Effect of Sevoflurane-dexmedetomidine and Sevoflurane-remifentanil on Biochemical Markers During Open Heart Surgery

Cukurova University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
level of laktat

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

remifentanil

Active Comparator

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

干预措施: Remifentanil (Drug)

remifentanil

Active Comparator

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

干预措施: Sevoflurane (Drug)

dexmedetomidine

Active Comparator

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.

干预措施: Dexmedetomidine (Drug)

dexmedetomidine

Active Comparator

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.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

level of laktat

时间窗: at 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass

Level of pyruvate

时间窗: at 20 minutes after cross clamp, 20 minutes after removal cross clamp and 10 minutes after cardiopulmonary bypass

level of CKMB

时间窗: at 20 minutes after cross clamp, 20 minutes after removal cross clamp, 10 minutes after cardiopulmonary bypass

level of Troponin-T

时间窗: at 20 minutes after cross clamp, 20 minutes after removal cross clamp, 10 minutes after cardiopulmonary bypass

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mediha turktan

assistant Professor

Cukurova University

研究点 (1)

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