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临床试验/NCT05648890
NCT05648890已完成不适用

Postoperative Cognitive Dysfunction as Geriatric Syndrome

Tomas Bata Hospital, Czech Republic1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
203
试验地点
1
主要终点
Postoperative Cognitive Dysfunction - Results of MMSE Before Operation

研究概览

简要总结

This study is testing cognitive function before and after the surgery, with patient's informed consent. Patients of interest are 65 year or older, undergoing surgery in general or regional anesthesia.

Investigators are using 3 tests. These are: MMSE (Mini Mental State Exam), TEGEST test (test of gestures) and Clock drawing test.

Tests after surgery are performed 2 days until discharge. The testing is anonymous, patient is assigned a number. Main aim of this study is to find a suitable quick test of cognitive function for clinical practice before surgery in general or regional anesthesia.

详细描述

This study is testing cognitive function before and after the surgery, with patient's informed consent. Patients of interest are 65 year or older, undergoing surgery in general or regional anesthesia.

Investigators are using 3 tests, MMSE - Mini Mental state exam, TEGEST - test of gestures and Clock drawing test with Baja scoring system.

MMSE is 30-point questionnaire. Maximum score for MMSE is 30 points. Score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. Score 21-23 indicate light cognitive impairment, score 20 - 11 indicate modern cognitive impairment, score 10 points or below indicate severe cognitive impairment.

Maximum score for TEGEST test is 6 points. Score of 4 or less indicates possible cognitive impairments. Patient is showed 6 gestures symbolizing senses (putting on glasses, smelling the flower, looking through telescope, eating with spoon, touching the cheek and picking up the telephone). After showing patient repeats 6 gestures.

Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for Clock drawing test with Baja scoring system is 5 points. Score 4 or less indicates possible cognitive impairments.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • age 65 or older
  • absence of sensory impairment (deafness)
  • full legal capacity
  • informed consent
  • ability to speak
  • elective or acute surgical procedure

排除标准

  • somnolence, coma
  • Glasgow coma scale 14 and less
  • known psychiatric disease
  • effect of premedication, drugs

结局指标

主要结局

Postoperative Cognitive Dysfunction - Results of MMSE Before Operation

时间窗: 2 days before operation

MMSE test was used by administrator before surgery. MMSE is 30 point questionnaire. Maximum score is 30 points. Score of 25 or higher is classed as normal cognitive capacity, 24 points and below is indicating possible congnitive impairment, 21-23 points are light cognitive impairment, 20-11 points are modern impairment, score 10 points or below indicate severe cognitive impairment. The test took 10 minutes approximately.

Postoperative Cognitive Dysfunction - Results of MMSE After Operation

时间窗: 3rd day after operation

MMSE test was used by administrator after surgery. MMSE is 30 point questionnaire. Score 25 or higher is know as normal cognitive capacity. Score 24 and below is indicating possible cognitive impairment, score 23-21 points are light cognitive impairment, 20-11 points are mild cognitive impairment, score 10 point or below indicate severe cognitive impairment. The test took 10 minutes approximately.

Postoperative Cognitive Dysfunction - TEGEST Test Before Operation

时间窗: 2 days before operation

TEGEST test is used by administrator before surgery. Patient is showed 6 gestures symbolizing senses (putting on glasses, smelling the flower, looking through telescope, eating with spoon, touching the cheek, and picking up the telephone). After showing the patient repeats 6 gestures. Maximum score is 6 points, score of 4 or less indicates possible cognitive impairments. At the end of testing before surgery administrator did access if patient has possible cognitive impairment. The test took 3 minutes.

Postoperative Cognitive Dysfunction - TEGEST Test After Operation

时间窗: 3rd day after operation

TEGEST test is used by administrator after surgery. Patient is showed 6 gestures symbolizing senses (putting on glasses, smelling the flower, looking through telescope, eating with spoon, touching the cheek, and picking up the telephone). After showing the patient repeats 6 gestures. Maximum score is 6 points, score of 4 or less indicates possible cognitive impairments. At the end of testing before surgery administrator did access if patient has possible cognitive impairment. The test took 3 minutes.

Postoperative Cognitive Dysfunction -Clock Drawing Test Before Operation

时间窗: 2 days before operation

Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time given by administrator, which is 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for is 5 points. Score 4 or less indicates possible cognitive impairment. The test took 3 minutes.

Postoperative Cognitive Dysfunction - Clock Drawing Test After Operation

时间窗: 3rd day after operation

Clock drawing test with Baja scoring system is a test, where patient is drawing clock with time given by administrator, which is 11:10 am. Administrator evaluates 12 digits in the clock, hour hands and pointing of the hour hands. Maximum score for is 5 points. Score 4 or less indicates possible cognitive impairment. The test took 3 minutes.

次要结局

  • Social Anamnesis During Preanesthesia Exam - Living Situation(2 days before operation)
  • Clinical Frailty Scale Before Operation(2 days before operation)
  • Social Anamnesis Before Operation- Type of Accommodation(2 days before operation)
  • Social Anamnesis - Stairs or Elevator(2nd day before operation)

研究者

发起方
Tomas Bata Hospital, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klára Nekvindová

MUDr. Klára Nekvindová - Principal Investigator

Tomas Bata Hospital, Czech Republic

研究点 (1)

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