Effect of Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
This study aims to compare the effect of intraoperative infusion of either lidocaine or dexmedetomidine on the incidence of postoperative delirium (POD) in elderly patients undergoing major surgeries. It also aims to evaluate the impact of both medications on intraoperative regional cerebral oxygen saturation (rSO₂).
详细描述
Postoperative delirium (POD) is a significant complication in elderly patients undergoing major surgery, with an incidence ranging from 10% to 50%, depending on patient and surgical factors.
Regional cerebral oxygen saturation (rSO₂), measured using near-infrared spectroscopy (NIRS), provides a real-time, non-invasive marker of cerebral perfusion. Previous studies have demonstrated that intraoperative declines in rSO₂ are associated with an increased risk of POD.
Lidocaine, an amide local anesthetic, has been shown to reduce neuroinflammation, improve microcirculation, and exert neuroprotective effects. It has been associated with low postoperative pain, reduced opioid consumption, and improved cognitive outcomes.
Dexmedetomidine, an α2-adrenergic agonist, is known for its sedative, analgesic, and sympatholytic effects. It has been shown to enhance cerebral perfusion, improve rSO₂, and reduce POD incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65years old.
- •Both sexes.
- •Physical status classification of II - III according to the American Society of Anesthesiologists (ASA).
- •Undergo elective non-cardiac surgeries.
排除标准
- •History of mental illness, neurological illness, or scoring less than 8 using the abbreviated mental test (AMT) before operation.
- •Severe hearing or visual impairment that may interfere with communication.
- •Severe renal or hepatic dysfunction.
- •Patients on central nervous system (CNS) medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
- •Contraindications to lidocaine or dexmedetomidine [e.g., allergy, severe bradycardia, atrioventricular (AV) block].
研究组 & 干预措施
Lidocaine group
Patients will receive an IV bolus (50 ml) of lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. This will be followed by intraoperative lidocaine infusion in a dose of 1.5mg /kg/hr till the end of surgery.
干预措施: Lidocaine (Drug)
Dexmedetomidine group
Patients will receive an IV bolus (50 ml) of dexmedetomidine in dose 0.5 μg/kg over 10 min before induction of anesthesia. This will be followed by intraoperative dexmedetomidine infusion in a dose of 0.3 μg/kg/hr till the end of surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Three days after surgery
Incidence of postoperative delirium (POD) will be recorded.
次要结局
- Degree of pain(24 hours postoperatively)
- Mean arterial blood pressure(Till end of surgery (Up to 2 hours))
- Regional cerebral oxygen saturation(Till end of surgery (Up to 2 hours))
- Postoperative opioid consumption(24 hours postoperatively)
- Incidence of adverse effects(24 hours postoperatively)
- Heart rate(Till end of surgery (Up to 2 hours))
研究者
Dina Hamdy Alhassanin
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University