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.
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.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico de la Universidad de Chile
Santiago, RM, 7690306
Research assistant, 229788209, bal.med@uchile.cl
Antonello Penna, Md PhD
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:
- - 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.
- - 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).
- - 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.
- Conditions
- Emergence From Anesthesia, EEG Power Spectra
- 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 group | Role | What they receive |
|---|---|---|
| Young adults | Young 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.
Anesthesia emergence time
Minutes from the end of the sevoflurane administration until eye opening to verbal stimulus
Measured: 60 minutes
Secondary outcomes (9)
Relative alpha power
Relative alpha power from the frontal EEG under general anesthesia
Measured: 60 minutes
Absolute alpha power
Absolute alpha power from frontal EEG under general anesthesia
Measured: 60 minutes
Extubation time
Time from the end of administration of sevoflurane until extubation
Measured: 60 minutes
Fentanyl requirements
Total dose of fentanyl (mcg) requirement during general anesthesia
Measured: 1 day
Propofol requirements
Total dose of propofol (mg) during general anesthesia
Measured: 1 day
Sevoflurane requirement
Total dose of sevoflurane (mL) used during general anesthesia
Measured: 1 day
Relative delta power
Relative delta power from frontal EEG under general anesthesia
Measured: 1 day
Excitation and inhibitory EEG balance
Excitation/inhibition balance from frontal EEG under general anesthesia
Measured: 1 day
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.
- First posted28 Nov 2025
- Study start30 Oct 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence From AnesthesiaStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07254975
- Acronym / sponsor ID
- ALPHA-SET / OAIC: 1526/25
- Conditions
- Emergence From Anesthesia, EEG Power Spectra
- Keywords
- emergence from anesthesia, general anesthesia, sevoflurane, alpha power
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Nov 2025 (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.
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.
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:
- - 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.
- - 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).
- - 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Procedure: Intraoperative EEG RecordingYoung adults (35-50 years) undergoing general anesthesia |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adult patients undergoing an elective surgery at the Hospital Clínico, University of Chile, Santiago, Chile.
Key inclusion criteria (3 listed)
- Elective surgery under general anesthesia
- Age 35-50 years
- ASA physical status I-II
Key exclusion criteria (8 listed)
- Neurological or psychiatric disorders
- Use of psychotropic drugs or opioids
- Altered consciousness
- BMI > 35 kg/m²
- Renal, cardiac, or hepatic dysfunction
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 |
|---|---|---|
| Intraoperative EEG RecordingPatients will be monitored with a frontal EEG during general anesthesia using the BIS Monitor to calculate alpha power | Procedure or surgery | Young adults |
Primary outcome
Anesthesia emergence time
Time frame: 60 minutes
Minutes from the end of the sevoflurane administration until eye opening to verbal stimulus
9 secondary outcomes
Relative alpha power
Time frame: 60 minutes
Absolute alpha power
Time frame: 60 minutes
Extubation time
Time frame: 60 minutes
Fentanyl requirements
Time frame: 1 day
Propofol requirements
Time frame: 1 day
Sevoflurane requirement
Time frame: 1 day
Relative delta power
Time frame: 1 day
Excitation and inhibitory EEG balance
Time frame: 1 day
Burst suppression time
Time frame: 1 day
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 20 Oct 2026.
- Background: PubMed 33177327Gutierrez 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.
- Individual participant dataSharing planned: Undecided
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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 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; AzTrials last refreshed its copy on 7 Nov 2026.