Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia

2. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

140

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
      • Shanghai, Čína
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Inhalational anesthesia
Jiný: Žádný zásah: Observační kohorta
Žádný zásah: Observační kohorta
Total intravenous anesthesia
Jiný: Žádný zásah: Observační kohorta
Žádný zásah: Observační kohorta

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
EEG trajectories during emergence from anesthesia
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
EEG spectral power characteristics
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ruijin Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

24. srpna 2026

Primární dokončení (Odhadovaný)

31. března 2027

Dokončení studie (Odhadovaný)

31. března 2027

Termíny zápisu do studia

První předloženo

24. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

2. září 2026

První zveřejněno (Aktuální)

8. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. září 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • MR-31-26-069242

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit