AnesthesiaNCT03587779
Comparison of Effect of Equi-MAC Anesthetics on PSI
A study testing Sevoflurane and Desflurane in people with Anesthesia, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia. 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
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2018to 22 Jan 2019
- Phase
- Interventional
- 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 aged between 19 and 65 yr
- patients with American Society of Anesthesiologists physical status classification I or II
- patients scheduled for elective surgery under volatile anesthesia
- patients obtaining written informed consent
Who cannot join
- patients with a history of any psychiatric or neurological disease
- patients receiving any medication affecting the autonomic or central nervous system
- patients with a history of alcohol or drug abuse
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Sevoflurane and Desflurane on Patient State Index: A Randomized Controlled Trial
The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.
Read the detailed description
There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.
- Conditions
- Anesthesia
- Being tested
- Sevoflurane, Desflurane
- Keywords
- patient state index, sevoflurane, desflurane, minimum alveolar concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.
DesfluraneDrug
Also called Suprane
Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Anesthesia is maintained with sevoflurane. Receives: Drug: Sevoflurane |
| Desflurane | Experimental | Anesthesia is maintained with desflurane. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient state index
patient state index value at a steady-state anesthesia of equi-MAC
Measured: After a 30-min waiting period from the induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start24 Jul 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 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
- Kyoung-Ho Ryu, M.D., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587779
- Sponsor's protocol ID
- 2018-05-045
- Status last verified
- Sep 2020
- First submitted
- 3 Jul 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Comparison of the Effect of Sevoflurane and Desflurane on Patient State Index: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03587779
- Acronym / sponsor ID
- 2018-05-045
- Conditions
- Anesthesia
- Keywords
- patient state index, sevoflurane, desflurane, minimum alveolar concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 16 Jul 2018 (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 aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.
Detailed description
There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluraneAnesthesia is maintained with sevoflurane. |
| Desflurane | Experimental | Drug: DesfluraneAnesthesia is 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 aged between 19 and 65 yr
- patients with American Society of Anesthesiologists physical status classification I or II
- patients scheduled for elective surgery under volatile anesthesia
- patients obtaining written informed consent
Key exclusion criteria (4 listed)
- patients with a history of any psychiatric or neurological disease
- patients receiving any medication affecting the autonomic or central nervous system
- patients with a history of alcohol or drug abuse
- pregnant or lactating 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: SevoraneThroughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration. | Drug | Sevoflurane |
| DesfluraneAlso: SupraneThroughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration. | Drug | Desflurane |
Primary outcome
patient state index
Time frame: After a 30-min waiting period from the induction of anesthesia
patient state index value at a steady-state anesthesia of equi-MAC
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: No
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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.
Kyoung-Ho 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 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 4 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.
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?
patient state index (time frame: After a 30-min waiting period from the induction of anesthesia). 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.