Emergence From AnesthesiaNCT07806903
Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia
An observational study of Emergence From Anesthesia, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence From Anesthesia
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2026to 31 Mar 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Qianzi Yang, +86 64370045, yqz12471@rjh.com.cn
About this study
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.
Read more
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.
- Conditions
- Emergence From Anesthesia
- Being tested
- No Intervention: Observational Cohort
- Keywords
- anesthesia emergency, recovery of consciousness, electroencephalography, EEG trajectory, total intravenous anesthesia, inhalational anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| Inhalational anesthesia | Not described Receives: Other: No Intervention: Observational Cohort | |
| Total intravenous anesthesia | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation.
Secondary outcomes (8)
EEG spectral power characteristics
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.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic exponent of the EEG power spectrum
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.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic offset of the EEG power spectrum
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.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Auxiliary EEG and monitor-derived parameters during emergence
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.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Length of stay in the postanesthesia care unit
Duration from admission to discharge from the postanesthesia care unit.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aldrete score at PACU discharge
Recovery status will be assessed using the Aldrete score at discharge from the postanesthesia care unit.
Measured: Before discharge from the postanesthesia care unit.
Richmond Agitation-Sedation Scale score at PACU discharge
Level of agitation and sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at PACU discharge.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Pain intensity measured using the Numeric Rating Scale at PACU discharge
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS) at PACU discharge, with higher scores indicating greater pain intensity.
Measured: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start24 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence From AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806903
- Sponsor's protocol ID
- MR-31-26-069242
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Trajectories During Emergence From Inhalational and Total Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT07806903
- Acronym / sponsor ID
- MR-31-26-069242
- Conditions
- Emergence From Anesthesia
- Keywords
- anesthesia emergency, recovery of consciousness, electroencephalography, EEG trajectory, total intravenous anesthesia, inhalational anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalational anesthesia | – | Other: No Intervention: Observational Cohort |
| Total intravenous anesthesia | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | Inhalational anesthesia, Total intravenous anesthesia |
Primary outcome
EEG trajectories during emergence from anesthesia
Time frame: 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.
8 secondary outcomes
EEG spectral power characteristics
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic exponent of the EEG power spectrum
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aperiodic offset of the EEG power spectrum
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Auxiliary EEG and monitor-derived parameters during emergence
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Length of stay in the postanesthesia care unit
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Aldrete score at PACU discharge
Time frame: Before discharge from the postanesthesia care unit.
Richmond Agitation-Sedation Scale score at PACU discharge
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Pain intensity measured using the Numeric Rating Scale at PACU discharge
Time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence From Anesthesia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianzi Yang, MD, PhD (+86 64370045, yqz12471@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG trajectories during emergence from anesthesia (time frame: From discontinuation of the anesthetic maintenance drugs until 30 minutes after tracheal extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.