Long Term Postoperative Cognitive Dysfunction in the Elderly Patients
Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: General anesthesia & Control
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.
|
The telephone interview for cognitive status (TICS), developed by Brandt et al. (1988), is one of the most popular telephone interview-based screening instruments.
Especially, the Korean version of TICS is translated more suitable for Korean culture with the permission of the authors of the original version.
The Korean version of TICS consists of 11 items, total score is 41.
다른 이름들:
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활성 비교기: Sevoflurane & Propofol & Dexmedetomidine
The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine.
These anesthetic drugs are used in general anesthesia generally.
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Sevoflurane is one of the most commonly used volatile anesthetic agents, particularly for outpatient anesthesia, and including in anesthesia of children and infants, and in veterinary medicine.
다른 이름들:
Propofol is highly protein-bound in vivo and is metabolized by conjugation in the liver.
The half-life of elimination of propofol has been estimated to be between 2 and 24 hours.
다른 이름들:
Dexmedetomidine is a sedative medication used by intensive care units and anesthesiologists.
It is relatively unusual in its ability to provide sedation without causing respiratory depression.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
기간: two years
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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.
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two years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
기간: two years
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Investigators will assess the postoperative cognitive dysfunction (POCD) after general anesthesia (sevoflurane, propofol and dexmedetomidine) and compare the occurrence rate of the POCD in 3 anesthetic methods.
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two years
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공동 작업자 및 조사자
수사관
- 연구 의자: Seung-Hoon Baek, Pusan National University Yangsan Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LPOCD60
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