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Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia

2 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

140

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
      • Shanghai, Cina
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Inhalational anesthesia
Altro: Nessun intervento: coorte di osservazione
Nessun intervento: coorte di osservazione
Total intravenous anesthesia
Altro: Nessun intervento: coorte di osservazione
Nessun intervento: coorte di osservazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EEG trajectories during emergence from anesthesia
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EEG spectral power characteristics
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ruijin Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

24 agosto 2026

Completamento primario (Stimato)

31 marzo 2027

Completamento dello studio (Stimato)

31 marzo 2027

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 settembre 2026

Primo Inserito (Effettivo)

8 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • MR-31-26-069242

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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