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临床试验/NCT02301676
NCT02301676Unknown4 期

Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients

Pusan National University Yangsan Hospital0 个研究点目标入组 190 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
190
主要终点
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.

研究概览

简要总结

The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD.

详细描述

In present aging society, a surgery in geriatric patient is increasing. Patients older than 60 year are particularly affected for postoperative cognitive dysfunction (POCD) (26-41%). The patients experiencing POCD are at an increased risk of death in the first year after surgery. So, POCD is important because it can influence to patient's quality of life.

In the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. So the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. The anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. The control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history.

After the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the Korean version of telephone interview for cognitive status (TICS). The Korean version of TICS was validated tool for examination of cognitive function and this tool and mini-mental state examination (MMSE) be linked directly. The test will be administered to spouse simultaneously by telephone.

Sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. Total sample size was calculated to 190.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia

排除标准

  • diseases of the central nervous system, including dementia (Mini Mental Examination Score <24),
  • consumption of major tranquilizers or antidepressants
  • previous neuropsychological testing
  • the patient's inability to comply and follow procedures or poor comprehension of the language used in the study.
  • Parkinson's disease
  • Patients with a severe visual or auditory handicap, illiteracy
  • alcoholism (intake of >5 units of alcohol daily during the last 3 months)
  • drug dependence
  • those not expected to complete the postoperative tests were excluded as well

研究组 & 干预措施

General anesthesia & Control

Active Comparator

After the surgery, the patients are discharged from the hospital, investigators will check the postoperative cognitive function 4 times: 1weak, 3months, 6months, 1 year later using the intervention "Korean version of telephone interview for cognitive status (TICS)". The test will be administered to spouse simultaneously by telephone.

干预措施: Korean version of telephone interview for cognitive status (Behavioral)

Sevoflurane & Propofol & Dexmedetomidine

Active Comparator

The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.

干预措施: Sevoflurane (Drug)

Sevoflurane & Propofol & Dexmedetomidine

Active Comparator

The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.

干预措施: propofol (Drug)

Sevoflurane & Propofol & Dexmedetomidine

Active Comparator

The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally.

干预措施: dexmedetomidine (Device)

结局指标

主要结局

The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.

时间窗: two years

Investigators will assess the postoperative cognitive dysfunction after general anesthesia in elderly patients compare to spouses which have no anesthetic history. Investigators will test participants using the Korean version of TICS and test will be done 1weak, 3months, 6months, 1 year after the surgery.

次要结局

  • The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs(two years)

研究者

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

Eun-Jung Kim

anesthesiologist

Pusan National University Yangsan Hospital

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