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临床试验/NCT05276648
NCT05276648Unknown不适用

Efficacy of Erector Spinae Plane Block on Postoperative Delirium in Patients Undergoing Lumbar Spine Surgery

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
128
试验地点
2
主要终点
Comparison of the effect of postoperative delirium (determined by CAM ICU test) in patients who underwent erector spina block after spinal surgery and those who did not.

研究概览

简要总结

Lumbar vertebra surgery is one of the most common surgical procedures.Delirium is common in geriatric patients after lumbar spinae surgery.postoperative delirium usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative delirium in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

详细描述

Postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are extremely common in geriatric surgical patients. After elective major joint replacement or other types of major surgery, about 5% to 15% of elders develop delirium and 25% to 40% and 12% to 15% developearly or late POCD. PDand POCD are associated with prolonged length of stay, discharge to a place other than home and higher 1 year mortality. In addition, delirium is associated with an accelerated trajectory of cognitive decline to dementia (1). The etiologies of both PD and POCD remain unknown. Controversy exists over whether delirium is a marker or risk factor for subsequent persistent cognitive impairment . The PD is an acute impairment of cognitive and or spatial/temporal perception,that can be diagnosed at the bedside with dedicated diagnostic tools. It has an acute onset and a fluctuating course, and therefore can be missed if not systematically tested. It is defined by three principal characteristics: altered consciousness; changes in cognitive abilities; recent and rapid onset . The POCD affects global cognitive functions for several months/years after surgery and anesthesia, diagnosis requires detailed neuropsychological testing.

Surgical interventions have been associated with severe pain and discomfort in the immediate perioperative period. Surgical anesthesia and the perioperative analgesic regimen aim toward complete intra-operative amnesia, profound analgesia, effective control of autonomic responses and rapid emergence. However, anesthesia, analgesia and sedation all utilize medications that might be implicated in the development of central nervous system (CNS) dysfunction. Elderly patients are more sensitive to the CNS effects of barbiturates, inhalationalanesthetics, benzodiazepines and opioids. Some medications frequently associated with delirium with or without POCD include opioids, anxiolytics, antidepressants, and corticosteroids.

There are studies regarding the effect of erektor spina field block on postoperative pain in vertebra surgery.The investigators will compare the effect on postoperative delirium of patients who underwent erector spina plane block after spinal surgery with those who did not.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 and older
  • ASA Physical Status 1-3;
  • Scheduled for elective hip surgery under spinal anesthesia
  • MMSE ≥ 20 (to exclude dementia)

排除标准

  • Severe visual or auditory disorder/handicaps
  • Bipolar disorder
  • major depression
  • schizophrenia
  • ASA physical status IV or V

结局指标

主要结局

Comparison of the effect of postoperative delirium (determined by CAM ICU test) in patients who underwent erector spina block after spinal surgery and those who did not.

时间窗: Change from baseline postoperative delirium at five days

CAM ICU IS THE TEST USED TO MEASURE DELIRIUM

次要结局

  • postoperative cognitive dysfunction assessment.we will use montreal cognitive assesment test(3 month later (one time))
  • postoperative chronic pain assessment.we will use brief pain scoring(3 month later (one time))

研究者

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

BULUT POLAT

DR

Aydin Adnan Menderes University

研究点 (2)

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