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临床试验/NCT05304559
NCT05304559Unknown不适用

Effects of S-ketamine and Continuous Iliac Fascia Space Block on Perioperative Neurological Cognitive Impairment and Postoperative Rehabilitation in Elderly Patients With Hip Fracture

Yangzhou University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年3月26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
发起方
入组人数
108
试验地点
1
主要终点
incidence of peioperative neurocognitive impairment

研究概览

简要总结

Elderly patients with hip fracture are older and have a high incidence of perioperative complications. the postoperative recovery of elderly patients with hip fracture is affected by hemodynamic instability and pain caused by fracture. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable in elderly patients with hip fracture.Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. It can more effectively reduce the perioperative pain of elderly patients with hip fracture.

详细描述

With the advent of the aging society, the incidence of hip fracture in elderly patients is increasing year by year, and the incidence of perioperative neurological cognitive impairment (PND) is increasing year by year. PND refers to postoperative brain dysfunction in patients without mental disorders, including postoperative delirium POD and postoperative cognitive dysfunction POCD. PND is more common in clinic, especially in the elderly. The main feature of PND is the long-term decline and decline of cognitive function after operation. PND not only prolongs the length of stay of patients, interferes with postoperative treatment, but even increases mortality. The pathogenesis of PND is not clear, and it is affected by many factors. Studies have shown that keeping intraoperative blood pressure at baseline to 10% above baseline can significantly reduce the incidence of PND. In addition, pain is also an important factor leading to the occurrence of PND. S-ketamine is the S-isomer of ketamine. Compared with traditional ketamine, S-ketamine has stronger analgesic effect and fewer adverse reactions of nervous system. The parasympathetic effect of S-ketamine can antagonize the circulatory inhibition of propofol and make the hemodynamics more stable. Iliac fascial space block (fasciailiacacompartmentblock,FICB) mainly depends on local anesthetics spreading to the femoral nerve, lateral femoral cutaneous nerve and obturator nerve in the iliofascial space to achieve analgesia in its dominant area. Ultrasound-guided iliac fascial space block can effectively reduce the amount of anesthetics and has shorter puncture time and fewer complications. In this study, a randomized controlled trial was conducted to observe the clinical effects of S-ketamine and ultrasound-guided iliac fascia block combined with general anesthesia in elderly patients with hip fracture, and to evaluate their clinical value.

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 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of hip fracture
  • Aged 65 or above
  • No mental and nervous system diseases
  • No pathological fractures, such as bone tumor, bone tuberculosis, osteomyelitis, etc
  • No puncture site infection
  • No hospital stay for more than 48 hours after operation

排除标准

  • Patients with severe cardiac, hepatic and renal dysfunction before operation
  • Long-term use of analgesics, sedatives and alcoholism
  • Patients with respiratory tract management difficulties (modified Ma's score is IV)
  • Previous neuropsychiatric diseases such as severe cerebrovascular, Alzheimer's disease, epilepsy and Parkinson's disease
  • Previous history of intracranial surgery or craniocerebral injury
  • Severe vision, hearing, language impairment or other reasons unable to communicate
  • Allergic or contraindicated to ropivacaine or non-steroidal anti-inflammatory drugs (NSAID)
  • Emergency surgery or trauma patients.

研究组 & 干预措施

Drug group

Experimental

S-ketamine 0.1mg/kg was injected intravenously during anesthesia induction and esmolamine 0.1mg/ (kg.h) was injected intravenously during anesthesia maintenance.S-Ketamine was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.

干预措施: S-Ketamine (Drug)

Device group

Experimental

The hip fracture was diagnosed clinically on admission and ultrasound-guided iliofascial space block was performed after evaluation, and the analgesia lasted until 2 days after operation.

干预措施: Continuous iliac fascia space block (Device)

Normal saline group

Placebo Comparator

normal saline 0.1ml/kg was injected intravenously during anesthesia induction and normal saline 0.1ml/ (kg.h) was injected intravenously during anesthesia maintenance.normal saline was put into the analgesia pump as an adjuvant for continuous analgesia until 2 days after operation.

干预措施: Normal saline (Drug)

结局指标

主要结局

incidence of peioperative neurocognitive impairment

时间窗: Perioperative period

incidence of peioperative neurocognitive impairment

次要结局

未报告次要终点

研究者

发起方
Yangzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yangtian Shuang

Resident physician

Yangzhou University

研究点 (1)

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