AnesthesiaPhase 3NCT02872389
Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia
A Phase 3 study testing Sevoflurane and Desflurane in people with Anesthesia, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2016to 6 Dec 2016
- Phase
- Phase 3
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing arthroscopic knee surgery under general anesthesia using volatile anesthetics
- patients with american society of anesthesiologist physical status I, II
- patients aged 19-65 years
- patients obtaining written informed consent
Who cannot join
- patients with a history of any psychiatric or neurological disease
- patients who had received any medication affecting the central nervous system
- patients who had received medication affecting the sympathetic or parasympathetic nervous systems
- patients undergoing tracheal intubation for airway management
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Power Spectral Analysis of the Electroencephalogram During Equi-MAC Sevoflurane vs. Desflurane Anesthesia: A Randomized Controlled Trial
The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.
Read the detailed description
Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there were no studies that demonstrate the difference of hypnotic potency using power spectral analysis of electroencephalographic signals (e.g., spectral edge frequency 95%, total power, % value of each bandage). The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.
- Conditions
- Anesthesia
- Being tested
- Sevoflurane, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called SEVO
Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
DesfluraneDrug
Also called DES
Anesthesia was maintained with desflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Anesthesia was maintained with sevoflurane. Receives: Drug: Sevoflurane |
| Desflurane | Experimental | Anesthesia was maintained with desflurane. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral edge frequency 95% value
EEG variables were measured after meeting steady-state anesthesia of 1 MAC.
Measured: During about 30 min study period
Secondary outcomes (1)
Bispectral index
Bispectral index measurements were made after meeting steady-state anesthesia of 1 MAC.
Measured: During about 30 min study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start16 Aug 2016
- Primary completion6 Dec 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital
- Investigators
- Kyoungho Ryu, M.D., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872389
- Sponsor's protocol ID
- KBSMC 2016-07-033
- Status last verified
- Sep 2020
- First submitted
- 10 Aug 2016
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Spectral Analysis of the Electroencephalogram During Equi-MAC Sevoflurane vs. Desflurane Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02872389
- Acronym / sponsor ID
- KBSMC 2016-07-033
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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 purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.
Detailed description
Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there were no studies that demonstrate the difference of hypnotic potency using power spectral analysis of electroencephalographic signals (e.g., spectral edge frequency 95%, total power, % value of each bandage). The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluraneAnesthesia was maintained with sevoflurane. |
| Desflurane | Experimental | Drug: DesfluraneAnesthesia was maintained with desflurane. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing arthroscopic knee surgery under general anesthesia using volatile anesthetics
- patients with american society of anesthesiologist physical status I, II
- patients aged 19-65 years
- patients obtaining written informed consent
Key exclusion criteria (5 listed)
- patients with a history of any psychiatric or neurological disease
- patients who had received any medication affecting the central nervous system
- patients who had received medication affecting the sympathetic or parasympathetic nervous systems
- patients undergoing tracheal intubation for airway management
- pregnant women
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 |
|---|---|---|
| SevofluraneAlso: SEVOAnesthesia was maintained with sevoflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. | Drug | Sevoflurane |
| DesfluraneAlso: DESAnesthesia was maintained with desflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. | Drug | Desflurane |
Primary outcome
Spectral edge frequency 95% value
Time frame: During about 30 min study period
EEG variables were measured after meeting steady-state anesthesia of 1 MAC.
1 secondary outcome
Bispectral index
Time frame: During about 30 min study period
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 3 Sep 2020.
- 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. This study is not recruiting at the moment.
Kyoungho Ryu, M.D. principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane and Desflurane in people with Anesthesia, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 4 inclusion and 5 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 3 Sep 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Spectral edge frequency 95% value (time frame: During about 30 min study period). 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 3 Sep 2020.