Neuroprotection During Open Heart Surgery Propofol Versus Ketofol
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Cerebral oxygenation
研究概览
简要总结
Millions of individuals with coronary artery, or valvular heart disease have been given a new chance at life by heart surgery, but the potential for neurological injury is a great risk .Neural complications - including neurocognitive dysfunction and ischemic complications are complications of cardiac surgery that can restrict the improved quality of life.
Propofol is one of the most popular agents used for induction of anesthesia. propofol reduces cerebral blood flow but maintains coupling with cerebral metabolic rate for oxygen and decreases intracranial pressure, allowing optimal intraoperative conditions.
Ketamine is a non-competitive antagonist of NMDA receptors that has well documented neuroprotective effects against ischemic brain injury and glutamate-induced brain injury. ketamine has neuroprotective effects against oxygen-glucose deprivation injury
详细描述
The aim of the study is to evaluate neuroprotective effect of mixture of propofol and ketamine (ketofol) as compared to propofol after open heart surgery.
Induction;
- Pre-oxygenation with100% O2 for 3 min.
- Morphine 0.1-0.15 mg/kg
- Fentanyl, dose 3-5 mcg/kg.
- hypnotic agent differs for each group:
- Propofol group: Propofol, dose 0.5-2 mg/kg.
- Ketofol group: Ketofol,( dose 0.25-1 mg/kg propofol plus 0.25-1 mg/kg ketamine diluted in normal saline with maintained 1:1 ratio between propofol and ketamine. )
Catheterization:
- Central venous catheter: A suitable central venous catheter will be inserted into Right subclavian vein under complete aseptic technique using seldinger technique.
- Jugular bulb catheterization: Patients is placed in supine position with mild neck extension. The head is placed in neutral position with mild tilt to the opposite side of insertion. Under complete aseptic conditions, the anatomical landmarks for the right internal jugular vein will be identified (at the level of cricoid cartilage, medial to the sternomastoid muscle and lateral to a palpable internal carotid artery). The internal jugular vein will be then cannulated by retrograde insertion of a catheter for sampling of the jugular venous bulb blood. Catheter will be advanced till resistance of the skull base is reached then withdrawn about 1 to 2 mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
- Double blind study
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 70 years of either sex.
- •Patients scheduled for elective cardiac surgery using cardiopulmonary bypass (CPB) either valve surgery or coronary artery bypass surgery
排除标准
- •Patient refusal.
- •Morbidly obese patients.
- •Patients with uncontrolled diabetes.
- •Patients with pre-existing neurological disease or using anti-psychotics. Severe or uncontrolled renal, hepatic or endocrinal diseases.
- •Pregnancy, post-partum or lactating females
- •Allergy to one of the agents used.
- •Emergency cardiac surgery.
- •Re-do surgery.
研究组 & 干预措施
propofol group
- Propofol infusion, 25-150mic/kg/min.
- Fentanyl infusion, 1-2 mcg/kg/h.
- Atracurium infusion, 3-12 mic/kg/min
干预措施: propofol (Drug)
结局指标
主要结局
Cerebral oxygenation
时间窗: from start of surgery and for 24 hours postoperative
Cerebral oxygenation as indicated by calculation of: 1. Arterio-Jugular oxygen content difference. 2. Estimated cerebral metabolic rate for O2(eCMRO2) eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ....... Ca jO2 is arterio-jugular O2 content difference. * PaCO2 is arterial CO2 tension
次要结局
- blood pressure measurement(from start of surgery and for 24 hours postoperative)
研究者
ghada fouad
associate professor of anesthesia
Mansoura University