跳至主要内容
临床试验/NCT07165236
NCT07165236招募中不适用

Association of Perioperative Cognitive Dysfunction With Circulating Biomarkers of Neurological Damage in Patients Underging Transurethral Resection of Bladder Tumor

Osijek University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年11月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
to examine whether the current cognitive state as measured by the Mini-Mental State Examination (MMSE) changes after the patient is exposed to surgery and general anesthesia.

研究概览

简要总结

Bladder tumor is one of the most widespread tumors in the world, with increasing prevalence at the global level. One of the procedures in patients with bladder tumors is transurethral resection of the bladder (TURM) most often performed endoscopically under general anesthesia. This patient population has certain characteristics in common. One of them is exposure to common risk factors for the formation of bladder tumors, such as aniline dyes and solvents. These substances are associated with the onset of neurodegeneration and oxidative stress. Smoking is another factor that affects the formation of bladder tumor. A significant part of patients with bladder tumor are an elderly population, which is repeatedly exposed to surgical procedures, with numerous comorbidities, with a high risk of postoperative complications and the development of perioperative cognitive deficits, which can further complicate the postoperative course and further treatment. In the group of patients with a bladder tumor who will undergo TURM, no evaluation of risk factors related to perioperative cognitive deficit was performed, nor was there an examination of the perioperative cognitive deficit itself. In them, the identification of factors for postoperative cognitive disorder is essential. The concept of clinical frailty is becoming more important and relevant when providing healthcare services to patients. The use of the clinical frailty scale as a tool in clinical practice provides information on the adequate direction of care for patients. Decrease in muscle strength can lead to limitations in the functioning of a certain individuals. In recent years muscle strength has come to be a very important component of health, regardless of a person's age and clinical condition.The hand grip test is a test used to measure the maximum isometric strength of the hand and forearm muscles. The MMSE test and MoCA are the most frequently used methods in the detection of cognitive impairment in clinical and research fields. In addition to laboratory indicators of organic function, circulating indicators of neuroinflammation, like S100B and neuron-specific enolase, will be correlated with the patient's cognitive status.So far, no research has been conducted on the dynamics of indicators of organic function, circulating indicators of neuroinflammation, perioperative cognitive changes and clinical fraility in patients undergoing bladder tumor operation.

详细描述

Bladder tumor is one of the most widespread tumors in the world, with increasing prevalence at the global level. It is the most common malignant disease of the urinary system. One of the procedures in patients with bladder tumors is transurethral resection of the bladder. This procedure is most often performed endoscopically under general anesthesia. The number of patients undergoing this type of procedure is increasing.

This patient population has certain characteristics in common. One of them is exposure to common risk factors for the formation of bladder tumors, such as aniline dyes and solvents. These substances are also associated with the onset of neurodegeneration and oxidative stress. For this reason, cognitive dysfunction can be expected in this patient population in addition to bladder cancer.

Another factor that affects the formation of bladder tumors is smoking. The connection between smoking and the formation of bladder tumors is the presence of carcinogenic substances in the urine of people who smoke, including aromatic amines. Likewise, cigarette smoke itself is harmful, as it also contains numerous carcinogenic substances, which are absorbed from the lungs into the bloodstream, and then reach the bladder via the kidneys. Given that urine is present in the bladder for a long time, its mucosa is exposed to these carcinogenic substances. Carcinogenic substances produced during smoking also lead to an indirect increase in risk, because they damage the immune system of people and lead to the development of inflammatory processes. Smoking is also one of the risk factors associated with the weakening of a person's cognitive status.

A significant part of patients with bladder tumor are an elderly population, which is repeatedly exposed to surgical procedures, with numerous comorbidities, with a high risk of postoperative complications and the development of perioperative cognitive deficits, which can further complicate the postoperative course and further treatment. Postoperative cognitive deficit includes cognitive disorders in the postoperative period, which are associated with numerous complications, which can lead to loss of independence in patients, increased morbidity and mortality, and increase the costs of treatment. In the group of patients with a bladder tumor who will undergo transurethral resection of the bladder, no evaluation of risk factors related to perioperative cognitive deficit was performed, nor was there an examination of the perioperative cognitive deficit itself.

Considering that this is an elderly population, it is expected that some patients will already be frail before the operation with the presence of a significant degree of dementia. In them, the identification of factors for postoperative cognitive disorder is essential, with the aim of taking measures to prevent the deterioration of their impaired general health condition. The concept of clinical frailty is becoming more and more important and relevant when providing healthcare services and healthcare to patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients from 18-80 years,
  • elective operations of tumor bladder cancer (TUR),
  • patients can communicate,
  • patients who can sign the information consent and questionnaires

排除标准

  • patients under the age of 18,
  • patients above 80 years,
  • patients who are unable to communicate
  • patients who do not understand informed consent for the research,
  • patients who are unable to write
  • emergency surgery,
  • patients with proven hypersensitivity to some of the drugs used in the study
  • patients in a state of shock, septic, or hemorrhagic patients with neurodevelopmental disorders

结局指标

主要结局

to examine whether the current cognitive state as measured by the Mini-Mental State Examination (MMSE) changes after the patient is exposed to surgery and general anesthesia.

时间窗: from baseline - 24 hours after surgery- 48 hours after surgery

Scores are generally interpreted as follows: 25-30: Normal result; 20-25: Mild cognitive impairment; 10-20: Moderate cognitive impairment; 0-10: Severe cognitive impairment. Cognitive test MMSE would be done after before surgery, 24 hours after surgery and 48 hours after surgery

To examine whether the current cognitive state, as measured using the Montreal Cognitive Assessment (MoCA), changes after the patient is exposed to surgery and general anesthesia.

时间窗: from baseline - 24 hours after surgery- 48 hours after surgery

The total possible score is 30 points; a score of 26 or above is considered normal. Cognitive test would be done before surgery, 24 hours after surgery, 48 hours after surgery.

次要结局

  • to examine changes in s100b in the perioperative period(baseline - 2hours after surgery - 24hours after surgery)
  • to examine changes in NSE in the perioperative period(baseline - 2hours after surgery- 24hours after surgery)
  • to examine changes in IL4 in the perioperative period(baseline - 2hours after surgery- 24hours after surgery)
  • to examine changes in iIL6 in the perioperative period(baseline - 2hours after surgery- 24hours after surgery)

研究者

发起方
Osijek University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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