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.
ALPHA-SET
1 other identifier
observational
70
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2025
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
November 19, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
November 28, 2025
October 1, 2025
9 months
November 19, 2025
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anesthesia emergence time
Minutes from the end of the sevoflurane administration until eye opening to verbal stimulus
60 minutes
Secondary Outcomes (9)
Relative alpha power
60 minutes
Absolute alpha power
60 minutes
Extubation time
60 minutes
Fentanyl requirements
1 day
Propofol requirements
1 day
- +4 more secondary outcomes
Study Arms (1)
Young adults
Young adults (35-50 years) undergoing general anesthesia
Interventions
Patients will be monitored with a frontal EEG during general anesthesia using the BIS Monitor to calculate alpha power
Eligibility Criteria
Young adult patients undergoing an elective surgery at the Hospital Clínico, University of Chile, Santiago, Chile.
You may qualify if:
- Elective surgery under general anesthesia
- Age 35-50 years
- ASA physical status I-II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33177327BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
November 28, 2025
Record last verified: 2025-10