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Emergence From AnesthesiaALPHA-SETNCT07254975

Anesthetic Sensitivity Assessed by Alpha Band Power and Its Association With Emergence Time From Sevoflurane General Anesthesia in Young Adults.

An observational study of Emergence From Anesthesia and EEG Power Spectra, run by University of Chile at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to determine the relationship between brain activity patterns and recovery time in adult patients (ages 35-50, ASA I-II) undergoing elective general anesthesia. Read more about this study

Who is it for?
Ages 35 to 50 years
Conditions the study is for
Emergence From Anesthesia, EEG Power Spectra
What is being tested?
Intraoperative EEG Recording
Type of treatment
Surgery or procedure
How many people
70 participants
Where
1 siteChile
Study dates
30 Oct 2025to 31 Aug 2027
How long will I take part?
1 Day
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 35 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Young adult patients undergoing an elective surgery at the Hospital Clínico, University of Chile, Santiago, Chile.

Who may be able to join

  • Elective surgery under general anesthesia
  • Age 35-50 years
  • ASA physical status I-II

Who cannot join

  • Neurological or psychiatric disorders
  • Use of psychotropic drugs or opioids
  • Altered consciousness
  • BMI > 35 kg/m²
  • Renal, cardiac, or hepatic dysfunction
  • Emergency surgery
  • Pregnancy
  • Regional anesthesia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antonello Penna, MD, PhD contact

+56229788209

apenna@uchile.cl

Chile1 site, 1 recruiting
  • Hospital Clinico de la Universidad de Chile

    Santiago, RM, 7690306

    Research assistant, 229788209, bal.med@uchile.cl

    Antonello Penna, Md PhD

    Recruiting

Other trials in Chile

About this study

Official title: An Observational Prospective Study of Anesthetic Sensitivity Assessed by Alpha Band Power and Its Association With Emergence Time From Sevoflurane General Anesthesia in Young Adults.

The goal of this observational study is to determine the relationship between brain activity patterns and recovery time in adult patients (ages 35-50, ASA I-II) undergoing elective general anesthesia.

The main question it aims to answer is:

  • Does a lower magnitude of intraoperative alpha wave power correlate with a longer time for patients to emerge from general anesthesia?

Participants will:

  • Undergo a standardized general anesthesia (GA) protocol for elective surgery.
  • Have their EEG activity recorded using a standard clinical BIS™ anesthetic depth monitor during the procedure.
  • Have their time to awakening precisely measured after the cessation of anesthetic gases.
Read the detailed description

General anesthesia (GA) is an essential technique in modern medicine, used to induce unconsciousness, analgesia, and immobility in patients during surgical procedures. Since no single drug can achieve all these conditions, a combination of agents acting on the central nervous system (CNS) is employed. These include GABAergic hypnotics, such as propofol and halogenated gases; opioids, such as remifentanil and fentanyl; and neuromuscular blocking agents, such as rocuronium. The co-administration of these drugs generates multiple interactions that allow anesthesia to be induced and maintained under predictable conditions, solidifying the concept of "balanced anesthesia." However, one of the major challenges in its management is the adequate titration of drugs according to the individual needs of each patient, in order to avoid both overdosing and underdosing, both of which pose potential risks to patient safety.

In this context, electroencephalography (EEG) has emerged as a key tool for monitoring anesthetic depth, providing real-time information on cerebral activity. The analysis of electroencephalographic patterns and spectrograms, particularly alpha wave power, has proven to be a useful indicator of the degree of decreased cerebral activity during general anesthesia. Furthermore, previous studies suggest that alpha wave power may correlate with anesthesia recovery time (Gutierrez et al., Anesthesia \& Analgesia, 2021) and possibly with individual sensitivity to general anesthetics. However, this relationship has not yet been fully elucidated, as a systematic study confirming this correlation has not been conducted. Establishing a correlation between emergence time and alpha band power would allow us to determine individual sensitivity to the effects of general anesthetics.

General Objective:

To determine whether patients who are more sensitive to the effects of general anesthetics have a lower relative power in the alpha band and a longer emergence time from general anesthesia.

Specific Objectives:

  1. - To quantify the relative alpha power in the electroencephalogram (EEG) spectrogram using an anesthetic depth monitor during the maintenance phase of general anesthesia in the study cohort.
  2. - To precisely record the anesthetic emergence time, defined as the interval from the cessation of volatile anesthetic administration to the patient's recovery of consciousness (e.g., eye opening or response to verbal command).
  3. - To statistically determine the correlation and magnitude of association between the quantified relative alpha power and the measured anesthetic emergence time.

Working Hypothesis Patients exhibiting greater cerebral sensitivity to general anesthetics, as indicated by a lower magnitude of relative alpha power during the maintenance phase, will experience a statistically significant prolongation of the anesthetic emergence time.

Methodology Materials and Methods: Subjects Following approval by the Ethics Committee of the Hospital Clínico Universidad de Chile, an observational study will be conducted on a cohort of patients undergoing general anesthesia. Given that only parameters obtained from a monitor and the time it takes for a patient to recover consciousness will be observed, an exemption from obtaining informed consent was approved by the ethics committee.

Study Protocol Patients will undergo conventional general anesthesia without major interventions. A BIS™ anesthetic depth monitor, which is routinely used in clinical practice, will be utilized to record anesthetic depth. The anesthesiologist will be requested to document the drugs used and to maintain general anesthesia, as is normally performed at our hospital, with sevoflurane at a standard dose of 0.8 to 0.9 MAC. Once the surgery is finished and anesthetic emergence begins, the minute the sevoflurane supply is stopped will be recorded. The moment consciousness is recovered, determined by eye opening and response to verbal or tactile stimuli (as is typically done in all general anesthetics), will be recorded.

In detail, a traditional general anesthetic at the Hospital Clínico de la Universidad de Chile consists of:

  • Intravenous bolus administration of fentanyl at a dose of 3 mcg/kg.
  • Subsequently, intravenous lidocaine administration at a bolus dose of 1 mg/kg, followed by the administration of an intravenous bolus of propofol at a dose of 2 mg/kg.
  • Once the patient loses consciousness, the NMBA IV is administered at a dose of 0.6 mg/kg of rocuronium.
  • The patient is then orotracheally intubated and connected to a mechanical ventilator.
  • Anesthetic maintenance is achieved with sevoflurane and repeated doses of fentanyl and/or rocuronium as needed.
  • Basic and necessary monitoring at all times consists of an electrocardiogram, pulse oximetry, capnography, intermittent non-invasive blood pressure, and anesthetic depth monitoring.
  • For anesthetic emergence, the effect of neuromuscular blockers must be reversed, and sevoflurane is eliminated until the patient recovers consciousness.

As this is an observational study, the clinician responsible for the patient will administer the drugs they deem necessary and perform the relevant clinical measures; we will only record these actions.

Statistics A descriptive statistical analysis will be performed for each type of variable, expressing the results as percentages, medians, or means as appropriate. The records from the anesthetic depth monitor will be analyzed using MATLAB to determine the magnitude of the power in the alpha band. The sample size was calculated assuming that the alternative hypothesis (H1) for the linear correlation between alpha power and emergence time is r² = 0.4 ± 0.3, while the null hypothesis (H0) is r² = 0. Considering a statistical power of 90%, an alpha error of 0.05, a two-tailed analysis, and a possible loss of 20% of the data, it was determined that 70 patients are required (calculation performed with G*Power 3.1.9.4). Statistical analyses will be conducted using GraphPad Prism and R.

Being tested
Intraoperative EEG Recording
Keywords
emergence from anesthesia, general anesthesia, sevoflurane, alpha power

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative EEG RecordingProcedure or surgery

    Patients will be monitored with a frontal EEG during general anesthesia using the BIS Monitor to calculate alpha power

Study groups in NCT07254975
Study groupRoleWhat they receive
Young adultsYoung adults (35-50 years) undergoing general anesthesia
Receives: Procedure: Intraoperative EEG Recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anesthesia emergence time

    Minutes from the end of the sevoflurane administration until eye opening to verbal stimulus

    Measured: 60 minutes

Secondary outcomes (9)
  1. Relative alpha power

    Relative alpha power from the frontal EEG under general anesthesia

    Measured: 60 minutes

  2. Absolute alpha power

    Absolute alpha power from frontal EEG under general anesthesia

    Measured: 60 minutes

  3. Extubation time

    Time from the end of administration of sevoflurane until extubation

    Measured: 60 minutes

  4. Fentanyl requirements

    Total dose of fentanyl (mcg) requirement during general anesthesia

    Measured: 1 day

  5. Propofol requirements

    Total dose of propofol (mg) during general anesthesia

    Measured: 1 day

  6. Sevoflurane requirement

    Total dose of sevoflurane (mL) used during general anesthesia

    Measured: 1 day

  7. Relative delta power

    Relative delta power from frontal EEG under general anesthesia

    Measured: 1 day

  8. Excitation and inhibitory EEG balance

    Excitation/inhibition balance from frontal EEG under general anesthesia

    Measured: 1 day

  9. Burst suppression time

    Cumulative burst suppression time during general anesthesia

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start30 Oct 2025
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
70 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254975
Sponsor's protocol ID
OAIC: 1526/25
Acronym
ALPHA-SET
Status last verified
Oct 2025
First submitted
19 Nov 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gutierrez RG, Egana JI, Maldonado FA, Saez IA, Reyes FI, Soulat H, Purdon PL, Penna A. Association Between Lower Preoperative Cognition With Intraoperative Electroencephalographic Features Consistent With Deep States of Anesthesia in Older Patients: An Observational Cohort Study. Anesth Analg. 2021 Jul 1;133(1):205-214. doi: 10.1213/ANE.0000000000005262.

    PubMed 33177327

Questions about this trial

What is this clinical trial studying?

An observational study of Emergence From Anesthesia and EEG Power Spectra, run by University of Chile at 1 site in Chile.

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 3 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: looking for participants now, as of the sponsor's last update on 20 Oct 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 Chile. 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 Antonello Penna, MD, PhD (+56229788209, apenna@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anesthesia emergence time (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07254975, which also lists 1 linked publication.

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 20 Oct 2026.

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