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临床试验/CTRI/2024/10/075524
CTRI/2024/10/075524已完成4 期

Comparison of tissue perfusion using difference in partial pressure of venous and arterial Carbon dioxide difference during Sevoflurane inhalation versus propofol Infusion for maintenance of Anaesthesia In elective off-pump Coronary Artery Bypass Grafting surgery

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
1.To compare tissue perfusion between the two groups by calculation of the difference in the partial pressure of carbon dioxide in arterial, central, and mixed venous samples,

研究概览

简要总结

Tissue perfusion will be compared using difference in partial pressure of carbon dioxide in venous and arterial blood between patients maintained on sevoflurane inhalation and those who will be maintained on propofol infusion during off-pump coronary artery bypass grafting surgery. This value will be correlated with serum lactate levels obtained from arterial blood gas analysis. This study will be conducted in PT B. D. Sharma, PGIMS Rohtak. Study duration will be one year

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Adult patients (40 to 80 years of age), Both sex, American Society of Anesthesiology (ASA- II, III, Elective OPCABG surgery.

排除标准

  • Patients with left ventricular ejection fraction less than 30%, Patients with history of severe hepatic, renal dysfunction, Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50%, PaCO2 more than 60mmHg, Patients undergoing combined surgical procedures (CABG combined with valve surgery aortic procedure, and carotid surgery), Redo surgeries, Patients with sepsis and septic shock, Emergency CABG, Off- pump CABG converted to on pump, Patients with serum lactate more than 3.0 mmol/L preoperatively, Patients with associated valvular heart disease, Symptomatic peripheral artery disease, Pregnant patients, Patient refusal.

结局指标

主要结局

1.To compare tissue perfusion between the two groups by calculation of the difference in the partial pressure of carbon dioxide in arterial, central, and mixed venous samples,

时间窗: T0 (post induction).T1(2 hours post induction), T2 (4 hours post induction) and thereafter in post-operative ICU at T3 (3 hours post operatively), T4 (6 hours post operatively), T5 (18 hours postoperatively), T6 (24 hours postoperatively), T7 (48 hours postoperatively

2.To correlate the above with serum lactate levels.

时间窗: T0 (post induction).T1(2 hours post induction), T2 (4 hours post induction) and thereafter in post-operative ICU at T3 (3 hours post operatively), T4 (6 hours post operatively), T5 (18 hours postoperatively), T6 (24 hours postoperatively), T7 (48 hours postoperatively

次要结局

  • 1. To measure cardiac output and pulmonary artery catheter (PAC) derived parameters via thermodilution technique using cold saline injectate 2. To compare changes in haemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, central venous pressure) during intraoperative period in both the groups 3. To calculate the Vasoactive-Inotropic Score (VIS) 4. To compare the length of ICU stay 5. Complications / adverse events (if any)(T0 (post induction).T1(2 hours post induction), T2 (4 hours post induction) and thereafter in post-operative ICU at T3 (3 hours post operatively), T4 (6 hours post operatively), T5 (18 hours postoperatively), T6 (24 hours postoperatively), T7 (48 hours postoperatively))

研究者

发起方
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Manasmita Dalai

PGIMS Rohtak

研究点 (1)

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