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临床试验/CTRI/2023/06/053644
CTRI/2023/06/053644尚未招募不适用

Effect of dexmedetomidine on myocardial protection during propofol based total intravenous anaesthesia in patients undergoing open heart surgery: A randomised double-blinded controlled trial.

AIIMS JODHPUR1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS JODHPUR
入组人数
52
试验地点
1
主要终点
Troponin I

研究概览

简要总结

Pre-anaesthetic evaluation will be done for all patients, a day before surgery. All patients will be thoroughly explained about the procedure and informed consent will be obtained. The standard instruction of fasting will be given to all patients (2 hours for clear liquids and 6 hours for semisolid and solid food).

On the day of surgery, in operating room, routine monitoring including electrocardiogram, peripheral oxygen saturation, non-invasive blood pressure and Bi-spectral (BIS) electrode will be attached and baseline vitals will be recorded. A peripheral intravenous cannula (16 G) and right radial arterial cannula (18 G) will be secured under local anaesthesia.

Pre-operative cardiac Troponin I levels sent.

All patients will be induced with midazolam 0.05 mg/kg, fentanyl 10 μg/kg and Propofol at the rate 2mg/kg. Rocuronium 1-1.2 mg/kg will be given to facilitate tracheal intubation. Mechanical ventilation will be controlled using 50% oxygen with a tidal volume of 6–8 ml/kg. A normal end tidal carbon dioxide pressure (35–45 mmHg) will be adjusted the respiratory frequency at 12–16 breaths/min. Transesophageal echocardiograph and urine output will be monitored.

In the propofol group (group P), anaesthesia will be maintained with propofol 10 mg/kg/h throughout the intraoperative period. In Propofol and dexmedetomidine (group PD), the anaesthesia will be maintained with dexmedetomidine 0.5 mcg/kg bolus over 10 min than 0.4 mcg/kg/min throughout the surgical procedure and propofol at infusion rate of 2–10 mg/kg/h.

In both groups the muscle relaxation will be maintained with Rocuronium 0.1 mg/kg at every 60 minutes and the depth of anaesthesia will be maintained between 40-60.

The cold cardioplegia solution will be prepared by magnesium sulfate 2.5 g, potassium chloride 2 g, and sodium bicarbonate 0.5 g in 500 ml physiologic saline, and administered into the aortic root every 30 min. The CPB procedure and surgical techniques will be under moderate hypothermia (32-34 °C) were standardized. The CPB prime volume, 1000–1500 ml calculated by patient’s weight, containing balanced salt solution, mannitol, and. The perfusion pressure (50–70 mmHg) will be maintained by a continuous non-pulsatile blood-flow rate of 2.0–2.5 l/min/m�’2 during CPB. All patients will be weaned off CPB by the support of epinephrine and norepinephrine. The patients will be withdrawn from the study if the CPB time was less 60 min or over 240 min or repeated CPB will be more than two times.

After completion of surgery the anaesthetic drugs will be discontinued and patients will be shifted to ICU. In the ICU, the vasopressor requirement will be recorded and further blood sample for biochemical marker will be sent at 6 hours, 24 hours and 72 hours.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above
  • Belonging to American Society of Anaesthesiologists (ASA) physical status II.
  • IV and scheduled for open heart surgery.
  • Patients of either sex.
  • Scheduled for elective open heart surgery.

排除标准

  • Emergency surgery
  • Cross-clamp time more than 120 minutes
  • Combined CABG and valvular heart surgery
  • Prior cardiac surgery
  • Patients having chronic renal/ liver/ pulmonary disease
  • Preoperative mechanical ventilation.

结局指标

主要结局

Troponin I

时间窗: 24hours

次要结局

  • 1. To compare MB isoenzyme levels between both groups.(2. To compare need for inotropic and vasopressor support using Vaso-inotropic score(VIS) between both groups.)

研究者

发起方
AIIMS JODHPUR
申办方类型
Research institution and hospital

研究点 (1)

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