このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Effects of Preoperative Sleep Disorders on Perioperative Anesthesia Depth and Recovery Quality in Patients Undergoing Noncardiac Surgery

2026年6月29日 更新者：General Hospital of Ningxia Medical University

Effects of Preoperative Sleep Disorders on Perioperative Anesthesia Depth and Recovery Quality in Patients Undergoing Noncardiac Surgery: A Single-Center, Prospective, Observational Cohort Study

A Single-Center, Prospective Observational Cohort Study Comparing Perioperative Electroencephalographic Anesthesia Depth Parameters (Electroencephalographic Index, SE/RE Entropy, Burst Suppression Ratio) Between Patients With Preoperative Sleep Disorders and Those Without; To Identify the Independent Effects of Preoperative Sleep Disorders on the Speed of Electroencephalographic Recovery During Emergence, Electroencephalographic Status at Extubation, Intra-PACU Electroencephalographic Fluctuations, and Quality of Emergence.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Preoperative sleep disorder is a common perioperative comorbidity. It impairs central nervous system stability and anesthetic drug metabolism, delays postoperative recovery, and is strongly associated with delayed emergence from general anesthesia, emergence agitation, and postoperative cognitive decline. Electroencephalographic (EEG) monitoring enables continuous, quantitative assessment of anesthetic depth (including EEG index, entropy, and burst suppression ratio), which can reflect central nervous depression more sensitively than conventional vital sign monitoring. To date, there is a lack of evidence based on complete preoperative-intraoperative-postoperative continuous EEG data to clarify the correlations between sleep disorders, anesthetic depth, and emergence quality. This prospective cohort study will collect full-course EEG parameters throughout the perioperative period to identify the effects of preoperative sleep disorders on the stability of anesthetic depth, EEG recovery during emergence, and adverse emergence events, so as to provide evidence-based references for perioperative cerebral protection and precision anesthetic management.

Primary Outcome Measures Preoperative & Postoperative Polysomnography (PSG) indicators: Sleep Efficiency Index (SEI), Total Sleep Time (TST), Arousal Index (AI), and the proportional percentages of N1, N2, N3 stages within NREM sleep and REM sleep; assessments conducted on the night after surgery, postoperative Day 1 and postoperative Week 1.Intraoperative EEG parameters: mean value of EEG index, minimum EEG index value, cumulative duration when EEG index < 40, maximum Burst Suppression Ratio (BSR).Emergence-phase EEG indicators: recovery time of EEG index, EEG index at extubation, standard deviation of EEG fluctuation in Post-Anesthesia Care Unit (PACU).Emergence quality indicators: extubation time, PACU length of stay, incidence of emergence agitation.

Serum Brain-Derived Neurotrophic Factor (BDNF) levels collected at preoperative, intraoperative and postoperative time points.

研究の種類

観察的

入学 (推定)

80

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。

研究連絡先

  • 名前：Na Zhao, Doctoral Candidate
  • 電話番号：86-951-674-3252
  • メール：18995096494@163.com

研究連絡先のバックアップ

  • 名前：Li Xin Ni, Doctoral
  • 電話番号：86-951-674-3252

研究場所

  • 中国
    • Ningxia
      • Yinchuan、Ningxia、中国、750001
        • 募集
        • General Hospital of Ningxia Medical University
        • コンタクト：
        • コンタクト：
          • Li Xin Ni, Doctoral
          • 電話番号：86-951-674-3252

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

Patients scheduled for elective non-cardiac surgery under general anesthesia at our hospital will be enrolled in this study.

説明

Inclusion Criteria:

  1. - Aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ;
  2. Elective non-cardiac surgery with an expected operative duration longer than 2 hours;
  3. Preoperative Mini-Mental State Examination (MMSE) score ≥ 24;
  4. Completion of the Pittsburgh Sleep Quality Index (PSQI) assessment 1 day before surgery;
  5. Absence of severe cardiac, hepatic, renal or cerebral diseases, and no history of psychiatric or neurological disorders;
  6. Voluntary provision of written informed consent.

Exclusion Criteria:

  1. Preoperative severe cognitive dysfunction, history of traumatic brain injury or stroke;
  2. Long-term regular use of sedative-hypnotics, antidepressants or antipsychotics;
  3. Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ < 90% lasting for more than 5 minutes);
  4. Inability to cooperate with EEG monitoring or scale evaluation;
  5. Pregnancy or breastfeeding status.

Drop-out Criteria :

  1. Cancellation of scheduled surgery/anesthesia or postoperative admission to the intensive care unit (ICU);
  2. Patient withdrawal of study participation;
  3. Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ < 90% lasting for more than 5 minutes);
  4. Development of severe postoperative complications;
  5. Incomplete data collection or voluntary trial withdrawal.

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

コホートと介入

グループ/コホート
介入・治療
Exposed cohort (sleep disorder group)
Patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥7.
組み合わせ製品：Exposed cohort (sleep disorder group)
All participants receive standardized sevoflurane-based general anesthesia for elective non-cardiac surgery. Continuous perioperative electroencephalographic (EEG) monitoring is performed throughout induction, maintenance and emergence phase. Serial scale assessments including PSQI, PSG, MMSE, NRS and delirium evaluation, as well as serial serum BDNF testing are conducted at designated perioperative time points. This cohort consists of patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 7, defined as preoperative sleep disorders.
Control cohort (non-sleep disorder group)
Patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score <7.
組み合わせ製品：Control cohort (non-sleep disorder group)
All participants receive identical standardized sevoflurane-based general anesthesia and continuous full-course EEG monitoring during elective non-cardiac surgery. Uniform perioperative scale assessments (PSQI, PSG, MMSE, NRS, postoperative delirium screening) and serial serum BDNF detection are completed at unified time nodes. This control cohort includes patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score < 7 without preoperative sleep disturbance.

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
Emergence Time
時間枠："perioperative"
Time to emergence from anesthesia:the time interval from discontinuation of anesthetics to patient awakening
"perioperative"
Time for recovery of EEG index
時間枠：Perioperative

The EEG index recovery time during emergence was monitored using the Misamo depth-of-anesthesia monitor. The awake judgment thresholds were set as SE ≥ 85 and RE ≥ 90.

Shorter recovery time indicates rapid elimination of anesthetic suppression in the cerebral cortex and smoother emergence; significantly prolonged recovery time suggests accumulation of anesthetics and excessive cerebral cortical suppression.

Start point: Discontinuation of maintenance doses of propofol, sevoflurane and remifentanil (rescue analgesics alone are not counted as the drug withdrawal start time).

End point: The EEG index steadily reaches the awake threshold without decline for 10p
Perioperative

二次結果の測定

結果測定
メジャーの説明
時間枠
Dosage of anesthetics:
時間枠：Perioperative
Dosage of anesthetics: total consumption of propofol, remifentanil and sevoflurane administered from anesthesia induction to emergence.
Perioperative
incidence of postoperative delirium
時間枠：CAM assessments were performed and recorded on postoperative Day 1, Day 3 and Day 7.

Postoperative delirium was assessed using the Confusion Assessment Method (CAM), which evaluates four dimensions: 1. acute fluctuating course; 2. inattention; 3. disorganized thinking; 4. altered level of consciousness. Higher CAM scores indicate more severe delirium.

Score 0: No delirium Score 1-2: Subsyndromal delirium (mild early stage) Score ≥3: Confirmed delirium Score 5-7: Severe delirium
CAM assessments were performed and recorded on postoperative Day 1, Day 3 and Day 7.
Numerical Rating Scale (NRS) pain score
時間枠：Pain scores were recorded immediately after surgery and daily from postoperative Day 1 to Day 7.
The Numerical Rating Scale (NRS) was adopted to evaluate the postoperative pain trend from postoperative Day 1 to Day 7. Higher NRS scores indicate more severe pain.Scores of 1-3 indicate mild pain, 4-7 moderate pain, and 8-10 severe pain.
Pain scores were recorded immediately after surgery and daily from postoperative Day 1 to Day 7.
Incidence of postoperative nausea and vomiting (PONV)
時間枠：PONV assessments were conducted upon emergence from anesthesia after surgery, and on postoperative Day 1, Day 2 and Day 3.
Grade 0 No nausea or vomiting Normal Grade 1 Nausea only, no vomiting or retching Mild PONV Grade 2 Retching or intermittent vomiting, less than 2 episodes Moderate PONV Grade 3 Frequent vomiting (≥2 episodes) with gastric contents ejection Severe PONV requiring pharmacological intervention For patients with Grade 2 or above PONV, the event shall be recorded in the Adverse Event section of the CRF, with a notation on whether antiemetics are administered.
PONV assessments were conducted upon emergence from anesthesia after surgery, and on postoperative Day 1, Day 2 and Day 3.

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

General Hospital of Ningxia Medical University

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 (実際)

2026年6月16日

一次修了 (推定)

2027年1月31日

研究の完了 (推定)

2027年1月31日

試験登録日

最初に提出

2026年6月16日

QC基準を満たした最初の提出物

2026年6月29日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月30日

QC基準を満たした最後の更新が送信されました

2026年6月29日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ZN-2026-0615

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する