The Effect of Circadian Clock System on Perioperative Cognitive Function of Elderly Patients
2019年12月10日 更新者：Yanchao Yang、Shengjing Hospital
Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients aged 65 and above.
It refers to the cognitive function changes such as memory decline and attention loss after anesthesia and surgery.
In serious cases, people may also experience personality changes and decline in social behavior ability, which will develop into irreversible cognitive impairment.Some studies reported that 25.8% of elderly patients presented POCD one week after non-cardiac surgery, and the incidence at 3 months after surgery was still 9.9%, which could increase the mortality in the first year after surgery.In recent years, studies have also proved that POCD is associated with patients' inability to perform their original jobs after non-cardiac surgery.Postoperative cognitive dysfunction seriously affects the clinical outcome, in addition to medical costs and other issues will bring an impact on the society and family.With the aging of the population, how to prevent cognitive dysfunction in elderly patients is a major challenge for perioperative management.There is a certain correlation between circadian rhythm and the dosage of general anesthesia, and postoperative sleep disturbance may be related to the effect of anesthesia and surgery on circadian rhythm.Preoperative sleep deprivation is known to be an independent risk factor for postoperative cognitive dysfunction (POCD), but the circadian mechanisms involved after general anesthesia are not yet clear
調査の概要
研究の種類
介入
入学 (予想される)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Liaoning
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Shenyang、Liaoning、中国、110004
- 募集
- Junchao hospital Zhu
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コンタクト：
- Junchao h Zhu
- 電話番号：18940257257 18940257257
- メール：zhujc@sj-hospital.org
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～90年 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- preoperative sleep disorders
- did not receive any preoperative chemoradiotherapy
- the duration of surgery ≧3 hours
Exclusion Criteria:
- History of schizophrenia
- epilepsy
- parkinson's disease or myasthenia gravis
- Critical illness (preoperative American society of anesthesiologists (ASA) ASA >III)
- severe liver insufficiency (ChildePugh grade C)
- severe renal insufficiency (preoperative dialysis)
- neurosurgery
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Day group
60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group ( 8:00-12:00)
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120 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and in the Night Group (18:00-22:00)
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他の：Night group
60 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Night Group (18:00-22:00)
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120 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and in the Night Group (18:00-22:00)
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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 |
|---|---|---|
|
postoperative sleep quality of one night before surgery
時間枠：one night before the surgery
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use sleep monitor to test the sleep quality one night before surgery
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one night before the surgery
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postoperative sleep quality of first night after surgery
時間枠：the first night after surgery
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use sleep monitor to test the sleep quality first night after surgery
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the first night after surgery
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postoperative sleep quality of third night after surgery
時間枠：the third night after surgery
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use sleep monitor to test the sleep quality third night after surgery
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the third night after surgery
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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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Preoperative cognitive function test
時間枠：one day before surgery
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use MMSE(Mini-mental state examination) scale to test the cognitive function one day before surgery.
MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
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one day before surgery
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Postoperative cognitive function test of 6 weeks after surgery
時間枠：6 weeks after surgery
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use MMSE(Mini-mental state examination) scale to test the cognitive function 6 weeks after surgery.
MMSE is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
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6 weeks after surgery
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Postoperative cognitive function test of 1 year after surgery
時間枠：1 year after surgery
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use MMSE(Mini-mental state examination) scale to test the cognitive function 1 year after surgery.
MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
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1 year after surgery
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Postoperative cognitive function test of 3 years after surgery
時間枠：3 years after surgery
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use MMSE(Mini-mental state examination) scale to test the cognitive function 3 years after surgery.
MMSE(Mini-mental state examination) is a simple test assessing several categories, such as orientation to time and place, short term memory, recall, attention, calculation, language and visuo-spatial abilities.
Scores ranging from 30 to 24 usually indicate normal cognitive function, while lower scores suggest the presence of cognitive impairment: mild from 23 to 19, moderate from 18 to 10 and severe from 9 to 0
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3 years after surgery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2020年1月1日
一次修了 (予想される)
2022年11月30日
研究の完了 (予想される)
2022年12月31日
試験登録日
最初に提出
2019年12月10日
QC基準を満たした最初の提出物
2019年12月10日
最初の投稿 (実際)
2019年12月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年12月11日
QC基準を満たした最後の更新が送信されました
2019年12月10日
最終確認日
2019年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。