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临床试验/CTRI/2022/04/042240
CTRI/2022/04/042240尚未招募不适用

Prospective randomized control trial to compare the relationship between cerebral oxygen saturation and mild hypercapnia in patients undergoing off- pump Coronary Artery Bypass Grafting

UNMICRC1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
UNMICRC
入组人数
100
试验地点
1
主要终点
To investigate the relationship between mild hypercapnia and regional cerebral oxygen saturation (rSo2) during off -pump CABG.

研究概览

简要总结

A thorough pre-anaesthetic check-up will be done prior to surgery. Patients will be educated briefly about the anaesthesia procedure. All patients will be kept nil by mouth for 6 hours prior to surgery. Written and informed consent will be taken from all patients participating in the study. Patient’s confidentiality will be maintained at all times and patients will be duly informed about the study through patient information sheet before signing the informed consent.

On arrival to the operating room, monitors including five lead electrocardiogram, pulse oximeter  , capnography  will be connected. An intravenous access with 16G/18G cannula and a radial arterial line under local anaesthesia shall be achieved for IABP monitoring and for ABG sampling. Prior to induction of anaesthesia, cerebral oximetry sensors placed bilaterally over the fronto temporal area, and the baseline rSO2 values will be measured. The patient shall be given Inj Midazolam 0.3mg/kg, Inj Fentanyl 5-10 microgram/kg body weight and Inj vecuronium 0.1 mg/kg body weight shall be used for induction. The patient will be pre oxygenated for 3 minutes and then intubated with appropriate size endotracheal Tube. A 7 fr central line will be secured for administration of drugs (infusion of   Dobutamine /Milirinone,  Noradrenaline, Nitroglycerine) and for CVP monitoring. Anaesthesia will be maintained with fentanyl and sevoflurane in oxygen, air mixture. Muscle relaxant will be maintained with vecuronium boluses.

After induction patient will be  randomised to either targeted mild hypercapnia (TMH) or targeted normocapnia  (TN) group. Minute ventilation will be adjusted to maintain an end tidal carbon dioxide concentration of 45-55 mm Hg  just before LIMA harvesting in targeted mild hypercapnia (TMH) group and 35-40 mm Hg in targeted normocapnia (TN) group. Inj heparin 100 units/kg to maintain ACT level around 250.The fluid will be given as per CVP . The ionotrope will be decided by pre op or intra op condition of heart and hemodynamics.

The cerebral oxygen saturation (rSO2), heart rate (HR), Mean Arterial Pressure (MAP), end tidal CO2, , peripheral oxygen saturation (SPO2) monitoring done as baseline i.e before induction,  after LIMA harvesting, at each grafting proximal and distal, after protamine,  after shifting in ICU. ABG will be taken before induction, after LIMA harvesting, at each grafting proximal  and distal, after protamine, after shifting to ICU, 4,12, 24 hrs and 48  hrs after extubation.  The Standardized Mini-Mental State Examination (SMMSE) will be  performed preoperatively, at 8, 12 & 24 hrs post-extubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • OPCABG, EF>40%.

排除标准

  • PATIENTS ON ECMO OR IABP, REDO CABG SURGERY.

结局指标

主要结局

To investigate the relationship between mild hypercapnia and regional cerebral oxygen saturation (rSo2) during off -pump CABG.

时间窗: baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU?

次要结局

  • To observe intraoperative pH, bicarbonate concentration, serum potassium concentration and incidence of postoperative cognitive dysfunction.(baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU, 4 hrs, 12 hrs and 24 hrs)

研究者

发起方
UNMICRC
申办方类型
Research institution and hospital

研究点 (1)

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