A Comparison Between the Effect of Ketamine-lidocaine Versus Ketamine-fentanyl for Induction of Anesthesia on Cerebral Perfusion Guided by Near Infra-red Spectroscopy in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction Undergoing Elective Coronary Artery Bypass Graft Surgery: (A Randomized Controlled Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- average postinduction NIRS
研究概览
简要总结
This study compares ketamine/fentanyl versus ketamine/lidocaine in term of their impact on cerebral perfusion during CABG. No prior data address these effects, and the goal is to identify the induction regimen that better preserves cerebral oxygenation.
详细描述
Cerebral oximetry monitoring using Near-Infrared Spectroscopy (NIRS) Resting baseline rSO2 values will be obtained
in all patients, ketamine will be injected slowly at 1.5 mg/kg in 0.25 mg/kg increments until clinical loss of consciousness. After loss of consciousness, atracurium 0.5 mg/kg will be administered to facilitate tracheal intubation. Tachycardia and hypertension, (20% increase heart rate, blood pressure from baseline reading) will be managed by a 25 mcg-bolus of Fentanyl. Anesthesia will be maintained by isoflurane (adjusted to maintain end-tidal minimal alveolar concentration of 1-1.2 %) in oxygen/air mixture. Mechanical ventilation will be adjusted to maintain end-tidal CO2 of 35-40 mmHg Any episode of hypotension (defined as mean arterial pressure [MAP] < 70% of the baseline reading and/or MAP <65mmHg, will be managed by 5 mcg norepinephrine (which could be repeated if hypotension persists for 1-min, NE infusion will be started if persisted after 3 boluses). Ephedrine bolus will be give if hypotension was associated with bradycardia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with coronary artery disease
- •with moderate to severe left ventricular dysfunction (ejection fraction < 40%),
- •scheduled for elective CABG surgery
排除标准
- •associated chronic stroke, TIA , carotid occlusive disease( due to abnormal vasomotor activity), patients with known neurological impairment (cerebral infarction , dementia ), significant carotid artery stenosis ,
- •valvular heart disease,
- •persistent arrhythmias,
- •congestive cardiac failure,
- •on mechanical ventilation,
- •intra-aortic balloon pump,
- •emergency surgery,
- •and those with known allergy to any of the study's drugs,
- •severe systemic non-cardiac disease and
- •patients with baseline NIRS reading < 60%
- •Patients with dementia or visual or auditory impairment
研究组 & 干预措施
fentanyl group
fentanyl bolus during induction of anesthesia
干预措施: Fentanyl (IV) (Drug)
lidocaine group
lidocaine bolus during the induction of anesthesia
干预措施: lidocaine (Drug)
结局指标
主要结局
average postinduction NIRS
时间窗: every 5 min after induction of anesthesia until 20 min after
average values of NIRS reading after induction of anesthesia
次要结局
- postoperative acute kidney injury(after extubation until 30 days postoperative)
- wound infection(after extubation until 30 days postoperative)
- renal replacement therapy(after extubation until 30 days postoperative)
- mean arterial pressure(every minute after induction of anesthesia until 20 min after induction)
- heart rate(every minute after induction of anesthesia until 20 min after induction)
- NRIS(during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min)
- cerebral hypoperfusion(during induction, 1 min after induction, during intubation, then every 5 minutes for 20 min)
- hypotension(immediately after induction of anesthesia until 20 min after induction)
- extra fentanyl bolus(immediately after induction of anesthesia until 20 min after induction)
- postoperative myocardial infarction(after extubation until 30 days postoperative)
- postoperative stroke(after extubation until 30 days postoperative)