SevofluraneNCT04431557
The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.
An observational study of Sevoflurane and Propofol, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators will record 120 patients who received general anesthesia, their EEG data recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sevoflurane, Propofol
- How many people
- 268 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jul 2017to 19 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Adult, Older adult
Study population: The study population was focus on the patients who need schedule general anesthesia with low anesthesia risk (ASA I-II).
Who may be able to join
- ASA I-II
- scheduled surgery who need general anesthesia
Who cannot join
- allergy to the BIS patch
- not suitable for general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will record 120 patients who received general anesthesia, their EEG data recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.
Read the detailed description
The electroencephalography (EEG) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) which can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear.
The relationship between frontal EEG patterns and hypnotics remain poorly understood. The investigators only can tell the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to decompose EEG with HHT and find the energy shift during general anesthesia, compare with different anesthetics.
The investigators will record 120 patients who received general anesthesia, their EEG data recorded from BIS machine for EMD analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.
- Conditions
- Sevoflurane, Propofol
What is being measured
The primary outcome is the main question the study is designed to answer.
The gamma, beta, alpha and theta power of EEG
We will try to observe the differences between hypnotic medications through EEG decomposed and power analysis.
Measured: the total duration inclusions in operation room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start19 Jul 2017
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Fang Tsai, M.D., Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431557
- Sponsor's protocol ID
- 201509018RINB
- Status last verified
- Jul 2017
- First submitted
- 9 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.
- ClinicalTrials.gov ID
- NCT04431557
- Acronym / sponsor ID
- 201509018RINB
- Conditions
- Sevoflurane, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 16 Jun 2020 (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 investigators will record 120 patients who received general anesthesia, their EEG data recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.
Detailed description
The electroencephalography (EEG) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) which can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear.
The relationship between frontal EEG patterns and hypnotics remain poorly understood. The investigators only can tell the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to decompose EEG with HHT and find the energy shift during general anesthesia, compare with different anesthetics.
The investigators will record 120 patients who received general anesthesia, their EEG data recorded from BIS machine for EMD analysis, the investigators decomposed EEG signal to different oscillations and tried to observe the differences between hypnotic medications through EEG analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population was focus on the patients who need schedule general anesthesia with low anesthesia risk (ASA I-II).
Key inclusion criteria (2 listed)
- ASA I-II
- scheduled surgery who need general anesthesia
Key exclusion criteria (2 listed)
- allergy to the BIS patch
- not suitable for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The gamma, beta, alpha and theta power of EEG
Time frame: the total duration inclusions in operation room
We will try to observe the differences between hypnotic medications through EEG decomposed and power analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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. This study is not recruiting at the moment.
Feng-Fang Tsai, M.D. study director
National Taiwan University Hospital
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 Sevoflurane and Propofol, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jun 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gamma, beta, alpha and theta power of EEG (time frame: the total duration inclusions in operation room). 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 16 Jun 2020.