AnesthesiaNCT03570164
Hemodynamics for Equi-MAC Anesthesia
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 peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation 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
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2018to 13 Nov 2018
- 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 arthroscopic knee surgery under general anesthesia
- patients obtaining written informed consent
Who cannot join
- patients with a history of any disease associated with the autonomic nervous system
- patients receiving any medication affecting the sympathetic or parasympathetic nervous systems
- patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Vasodilative Effects Between Sevoflurane and Desflurane Using Peripheral Perfusion Index
The aim of this study is to compare the peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.
Read the detailed description
Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on vascular tissue and both are vasodilators. However, there has been no direct comparison of vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor tone. Therefore, the purpose of this study is to compare the peripheral perfusion index values produced by sevoflurane and desflurane at equipotent concentration in patients undergoing single-agent inhalation anesthesia.
- 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 Sevorane
End-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
DesfluraneDrug
Also called Suprane
End-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
| 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.
peripheral perfusion index
peripheral perfusion index value at a steady-state anesthesia of age-corrected 1.0 MAC
Measured: After a 30-min waiting period from the induction of anesthesia
Secondary outcomes (2)
mean arterial pressure
mean arterial pressure at a steady-state anesthesia of age-corrected 1.0 MAC
Measured: After a 30-min waiting period from the induction of anesthesia
heart rate
heart rate at a steady-state anesthesia of age-corrected 1.0 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 posted26 Jun 2018
- Study start18 Jun 2018
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
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 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
- 70 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
- NCT03570164
- Sponsor's protocol ID
- 2018-05-019
- Status last verified
- Oct 2019
- First submitted
- 15 Jun 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryu KH, Hwang SH, Shim JG, Ahn JH, Cho EA, Lee SH, Byun JH. Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):935-942. doi: 10.1016/j.bja.2020.07.050. Epub 2020 Sep 18.
PubMed 32958203
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vasodilative Effects Between Sevoflurane and Desflurane Using Peripheral Perfusion Index
- ClinicalTrials.gov ID
- NCT03570164
- Acronym / sponsor ID
- 2018-05-019
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 26 Jun 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 peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.
Detailed description
Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on vascular tissue and both are vasodilators. However, there has been no direct comparison of vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor tone. Therefore, the purpose of this study is to compare the peripheral perfusion index values produced by sevoflurane and desflurane at equipotent concentration 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 arthroscopic knee surgery under general anesthesia
- patients obtaining written informed consent
Key exclusion criteria (4 listed)
- patients with a history of any disease associated with the autonomic nervous system
- patients receiving any medication affecting the sympathetic or parasympathetic nervous systems
- patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse
- 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: SevoraneEnd-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period. | Drug | Sevoflurane |
| DesfluraneAlso: SupraneEnd-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period. | Drug | Desflurane |
Primary outcome
peripheral perfusion index
Time frame: After a 30-min waiting period from the induction of anesthesia
peripheral perfusion index value at a steady-state anesthesia of age-corrected 1.0 MAC
2 secondary outcomes
mean arterial pressure
Time frame: After a 30-min waiting period from the induction of anesthesia
heart rate
Time frame: After a 30-min waiting period from the induction of anesthesia
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 21 Oct 2019.
- Derived from this study: PubMed 32958203Ryu KH, Hwang SH, Shim JG, Ahn JH, Cho EA, Lee SH, Byun JH. Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):935-942. doi: 10.1016/j.bja.2020.07.050. Epub 2020 Sep 18.
- 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 21 Oct 2019. 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?
peripheral perfusion 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?
On the ClinicalTrials.gov record for NCT03570164, 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 21 Oct 2019.