NCT07806903

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

August 24, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

August 24, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 24, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

anesthesia emergencyrecovery of consciousnesselectroencephalographyEEG trajectorytotal intravenous anesthesiainhalational anesthesia

Outcome Measures

Primary Outcomes (1)

  • EEG trajectories during emergence from anesthesia

    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.

Secondary Outcomes (8)

  • EEG spectral power characteristics

    From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation

  • Aperiodic exponent of the EEG power spectrum

    From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation

  • Aperiodic offset of the EEG power spectrum

    From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation

  • Auxiliary EEG and monitor-derived parameters during emergence

    From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation

  • Length of stay in the postanesthesia care unit

    From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation

  • +3 more secondary outcomes

Study Arms (2)

Inhalational anesthesia

Other: No Intervention: Observational Cohort

Total intravenous anesthesia

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort

Inhalational anesthesiaTotal intravenous anesthesia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Central Study Contacts

Qianzi Yang, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 8, 2026

Study Start

August 24, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

September 8, 2026

Record last verified: 2026-08

Locations