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Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia

2026年9月2日 更新者:Ruijin Hospital

General anesthesia emergence is a critical transition during which patients recover from an anesthetic-induced unconscious state to consciousness. This period is associated with various early postoperative complications, including emergence agitation, postoperative nausea and vomiting, delayed recovery, and impaired recovery quality in the Post-Anesthesia Care Unit (PACU). Although total intravenous anesthesia (TIVA) and inhalational anesthesia (IA) are widely used maintenance strategies, differences in their effects on cerebral recovery patterns during emergence remain incompletely understood.

Conventional assessments of emergence, such as time to eye opening, extubation time, and clinical sedation assessments, mainly reflect behavioral recovery and cannot directly characterize the dynamic process of cerebral functional recovery. Electroencephalography (EEG) provides continuous and non-invasive measurement of cortical activity and may enable objective characterization of anesthetic emergence.

Previous studies suggest that emergence from anesthesia involves dynamic transitions among distinct EEG states rather than a simple reversal of anesthetic induction, and specific EEG trajectories may be associated with abnormal emergence and PACU delirium. Therefore, this single-center prospective observational cohort study aims to continuously collect emergence-phase EEG data from patients receiving TIVA or IA without altering clinical anesthesia management. The study will compare EEG trajectory characteristics, spectral features, and aperiodic parameters between different anesthesia maintenance modalities and explore their associations with emergence quality and early postoperative complications.

This study may provide further insights into neurophysiological patterns of anesthetic emergence and support future optimization of emergence monitoring and perioperative management.

調査の概要

状態

まだ募集していません

研究の種類

観察的

入学 (推定)

140

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

研究場所

      • Shanghai、中国
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • コンタクト:

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

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

This study will enroll adult patients aged 18-60 years who are scheduled to undergo elective non-cardiac and non-neurosurgical surgery under general anesthesia. Participants will receive routine clinical anesthesia management, and the choice of total intravenous anesthesia or inhalational anesthesia will be determined by the attending anesthesiologist according to clinical practice.

説明

Inclusion criteria

  1. Adults aged 18-60 years.
  2. Patients classified as American Society of Anesthesiologists (ASA) physical status I-III.
  3. Patients scheduled to undergo elective non-cardiac and non-neurosurgical surgery under general anesthesia.
  4. Expected duration of surgery ≥60 minutes.
  5. Expected intraoperative maintenance anesthesia with either total intravenous anesthesia (TIVA) or inhalational anesthesia .
  6. Patients who understand the study procedures and voluntarily provide written informed consent.

Exclusion Criteria

  1. History of central nervous system disorders, including epilepsy, Parkinson's disease, dementia, previous stroke with residual neurological deficits, or other clinically significant neurological diseases.
  2. Long-term use (≥4 weeks) of sedative-hypnotic drugs, antidepressants, antipsychotic medications, or other medications that may significantly affect central nervous system function.
  3. Pre-existing cognitive impairment or severe visual/hearing impairment preventing assessment of recovery of consciousness.
  4. Skin lesions, trauma, or other conditions affecting placement of frontal EEG electrodes.
  5. Emergency surgery, neurosurgery, cardiac surgery, planned deep sedation with postoperative intubation, or direct transfer to the intensive care unit after surgery.
  6. Severe intraoperative adverse events, including cardiac arrest, malignant hyperthermia, severe allergic reactions, major bleeding, or situations requiring substantial changes in the planned anesthesia maintenance strategy.
  7. Body mass index (BMI) ≥30 kg/m² or ≤18 kg/m².
  8. Refusal to participate or withdrawal of informed consent during the study.1. Adults aged 18-60 years, with no restriction on sex.

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
Inhalational anesthesia
介入なし: 観察コホート
Total intravenous anesthesia
介入なし: 観察コホート

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
EEG trajectories during emergence from anesthesia
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation.
Frontal EEG recordings will be analyzed to characterize spectral activity and its temporal evolution during emergence from general anesthesia. Prespecified EEG parameters will include delta-band spectral power and alpha/spindle-band spectral power derived from power spectral density estimates. These spectral features will be used to characterize EEG states and transitions during emergence, including state occupancy, transition timing, and transition sequences.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation.

二次結果の測定

結果測定
メジャーの説明
時間枠
EEG spectral power characteristics
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Frontal EEG recordings will be obtained during emergence from general anesthesia. The EEG will be segmented into consecutive prespecified epochs, and spectral analysis will be performed for each segment. Power spectral density will be calculated within the following frequency bands: delta, 0.5-4 Hz; theta, 4-8 Hz; alpha/spindle, 8-13 Hz; beta, 13-30 Hz; and gamma, 30-45 Hz. Absolute power and relative power will be calculated for each frequency band. Relative power will be defined as the power within each frequency band divided by the total spectral power across the prespecified analysis frequency range. The alpha-to-delta power ratio, alpha peak frequency, and alpha peak power will also be calculated. Gamma-band findings will be considered exploratory because of possible electromyographic contamination.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic exponent of the EEG power spectrum
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
The aperiodic exponent will be estimated from frontal EEG power spectra using a prespecified spectral parameterization method that separates periodic spectral peaks from the aperiodic 1/f-like background.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic offset of the EEG power spectrum
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
The aperiodic offset will be estimated from frontal EEG power spectra using a prespecified spectral parameterization method that separates periodic spectral peaks from the aperiodic 1/f-like background.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Auxiliary EEG and monitor-derived parameters during emergence
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Additional EEG-derived and monitor-generated parameters will be assessed during emergence from general anesthesia. Spectral edge frequency 90% (SEF90) will be calculated as the frequency below which 90% of the total EEG spectral power within the prespecified analysis frequency range is contained. In addition, the Ai Index and electromyographic (EMG) index generated by the EEG monitoring system will be recorded continuously during emergence.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Length of stay in the postanesthesia care unit
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Duration from admission to discharge from the postanesthesia care unit.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aldrete score at PACU discharge
時間枠:Before discharge from the postanesthesia care unit.
Recovery status will be assessed using the Aldrete score at discharge from the postanesthesia care unit.
Before discharge from the postanesthesia care unit.
Richmond Agitation-Sedation Scale score at PACU discharge
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Level of agitation and sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at PACU discharge.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Pain intensity measured using the Numeric Rating Scale at PACU discharge
時間枠:From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS) at PACU discharge, with higher scores indicating greater pain intensity.
From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation

協力者と研究者

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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 (推定)

2026年8月24日

一次修了 (推定)

2027年3月31日

研究の完了 (推定)

2027年3月31日

試験登録日

最初に提出

2026年8月24日

QC基準を満たした最初の提出物

2026年9月2日

最初の投稿 (実際)

2026年9月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月8日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • MR-31-26-069242

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