A randomized controlled clinical study to compare the effects of Normocapnia versus mild hypercapnia on cerebral oxygen saturation in patients undergoing off pump coronary artery bypass grafting at SMS Hospital , Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The change in intraoperative regional cerebral oxygen saturation (rSO2) on the right, left, and mean sides between the two groups—targeted mild hypercapnia and targeted normocapnia—during off-pump coronary artery bypass grafting surgery
研究概览
简要总结
This study is a prospective, randomized, parallel group, active controlled clinical trial at SMS Hospital comparing the effects of targeted mild hypercapnia (PaCO2 45-55 mmHg) versus targeted normocapnia (PaCO2 35-45 mmHg) on cerebral oxygen saturation and postoperative cognitive function in patients undergoing off pump coronary artery bypass grafting. The primary outcome is the change in intraoperative regional cerebral oxygen saturation measured at multiple surgical time points. Secondary outcomes include hemodynamic parameters, arterial blood gas values, duration of mechanical ventilation, standardized mini-mental state examination scores, and length of ICU/hospital stay. Randomization is via sequentially numbered, sealed, opaque envelopes, and the study is open label without blinding. The target sample size is 66 patients. The assessments occur intraoperatively and postoperatively up to 24 hours after extubation to evaluate cerebral oxygenation and cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed written consent
- •Patients of either sex age between 35 -70 years posted for off-pump CABG
- •Ejection fraction more than 40%
- •ASA Grade 2.
排除标准
- •Patient having preexisting cognitive dysfunction.
- •Known case of chronic obstructive pulmonary disease (COPD).
- •Redo CABG surgeries.
- •Associated valvular lesions .
- •Preexisting neurological disorder (History of Stroke).
- •The patients who required intra- aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) before leaving the operating room.
结局指标
主要结局
The change in intraoperative regional cerebral oxygen saturation (rSO2) on the right, left, and mean sides between the two groups—targeted mild hypercapnia and targeted normocapnia—during off-pump coronary artery bypass grafting surgery
时间窗: T0 Baseline ( Before Induction) | T1 (After induction) | T2 After LIMA Harvesting | T3 At each grafting distal site | T4 At each grafting proximal site | T5 After protamine administration | After shifting to ICU
次要结局
- Any complications or side effects observed during the study
- Changes in hemodynamic parameters (Heart Rate, Systolic & Diastolic Blood Pressure, Mean Arterial Pressure, Central Venous Pressure)
- Arterial Blood Gas Values(T0 Baseline (before induction))
- Duration of mechanical ventilation
- Standardized Mini-Mental State Examination (SMMSE) scores postoperatively for cognitive assessment(1. Preoperatively (before surgery))
- Length of ICU and Hospital Stay
研究者
Dr Anjum Saiyed
SMS Medical College and attached hospital , Jaipur