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临床试验/NCT07838909
NCT07838909已完成不适用

Effect of Intraoperative Ketamine Versus Lidocaine Infusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Surgery

Tanta University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Incidence of postoperative cognitive dysfunction

研究概览

简要总结

This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery.

详细描述

Hip arthroplasty remains one of the most commonly used and successful contemporary surgical interventions performed in older adults. Hip fractures in the elderly have emerged as a serious injury that incurs high medical costs and public resources due to long-term bed rest, limitations of independent daily living, or death, more than 28,000 hip fractures occur annually; this number is rapidly rising with the aging population) .

Despite successful surgery, patients still may suffer short- or long-term postoperative cognitive dysfunction , due to long operative times, extensive trauma, and the possibility of fat emboli .

POCD, which reflects a negative change in an individual's cognitive trajectory, has increasingly been recognized as a complication in elderly patients. It is characterized by disturbances in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia .

The potential pathogenesis of postoperative cognitive dysfunction involves neuroinflammation and oxidative stress secondary to anesthesia and surgery. Post-surgery inflammation is characterized by increased levels of inflammatory cytokines and mediators and vascular permeability. Excessive inflammation can disrupt the body's immune system, potentially leading to certain inflammation-related conditions .

postoperative cognitive dysfunction is a neurological dysfunction which may last for weeks, months or years and can delay recovery, extend hospital stays, and even increase patient mortality. The incidence of postoperative cognitive dysfunction varies between 20 and 40% in patients over 60 years old. Therefore, it is important to develop new strategies to prevent postoperative cognitive dysfunction , especially in elderly patients . However, there is still unclear. on the methods and treatments used to prevent and treat postoperative cognitive dysfunction , including dexmedetomidine, ketamine, ulinastatin, parecoxib, midazolam, lidocaine, and dexamethasone.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
66 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Both sexes of Elderly patient Aged >65 years.
  • •American Society of Anesthesiologists classification I-III.
  • •Undergoing hip surgery under spinal anesthesia.

排除标准

  • •Patient refusal.
  • •History of mental illness or scoring less than 8 using abbreviated mental test before operation as in table 3 .
  • •Obvious sinus bradycardia (heart rate of <50 beats per minute) or other serious cardiovascular diseases.
  • •Symptomatic cerebrovascular disease (such as previous stroke).
  • •History of liver and kidney dysfunction.
  • •Allergy to lidocaine or ketamine.
  • •Metabolic disorders and fluid, electrolytes disturbances.
  • •Alcohol dependence or drug abuse.
  • •Redo surgery or infectious complications.
  • •Central nervous system medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
  • •History of deep vein thrombosis.

研究组 & 干预措施

Group Ketamine

Experimental

Patients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery.

干预措施: Group Ketamine (Drug)

Group Lidocaine

Experimental

Patients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery.

干预措施: Group Lidocaine (Drug)

Group Placebo

Placebo Comparator

Patients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group.

干预措施: Group Placebo (Drug)

结局指标

主要结局

Incidence of postoperative cognitive dysfunction

时间窗: 3 days

次要结局

  • Postoperative pain score(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marian Reda Abdou Gerges

Assistant lecturer

Tanta University

研究点 (1)

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