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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
他の名前：
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アクティブコンパレータ：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.
|
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.
他の名前：
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.
他の名前：
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Seung-Hoon Baek、Pusan National University Yangsan Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LPOCD60
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