AnesthesiaPhase 3NCT02830243
Comparison of Analgesic Effect of Volatile Anesthetics
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 analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2016to 8 Oct 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 balanced general anesthesia using volatile anesthetics and remifentanil
- 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: The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index
The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.
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 bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.
- 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
End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
DesfluraneDrug
Also called DES
End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
| 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.
Remifentanil consumption (µg/kg/min)
Measured: During the intraoperative period
Secondary outcomes (1)
Target effective site concentration of remifentanil (ng/ml)
Measured: After at least 10 min of stable surgical pleth index values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start12 Jul 2016
- Primary completion5 Oct 2016
- Study completion8 Oct 2016
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 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, Kyoungho Ryu, Kangbuk Samsung Hospital
- Investigators
- Kyoungho Ryu, M.D., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830243
- Sponsor's protocol ID
- 2016-05-058
- Status last verified
- May 2018
- First submitted
- 9 Jul 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ryu KH, Kim JA, Ko DC, Lee SH, Choi WJ. Desflurane reduces intraoperative remifentanil requirements more than sevoflurane: comparison using surgical pleth index-guided analgesia. Br J Anaesth. 2018 Nov;121(5):1115-1122. doi: 10.1016/j.bja.2018.05.064. Epub 2018 Jul 4.
PubMed 30336856
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Analgesic Effect of Volatile Anesthetics Using Surgical Pleth Index
- ClinicalTrials.gov ID
- NCT02830243
- Acronym / sponsor ID
- 2016-05-058
- 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
- 12 Jul 2016 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 8 Oct 2016 (actual)
- First posted
- 12 Jul 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 analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index.
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 bispectral index values. However, the difference between analgesic effects of volatile anesthetics have not yet been investigated. The purpose of this clinical trial is to compare analgesic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using surgical pleth index-guided remifentanil infusion.
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 balanced general anesthesia using volatile anesthetics and remifentanil
- 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: SEVOEnd-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50. | Drug | Sevoflurane |
| DesfluraneAlso: DESEnd-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50. | Drug | Desflurane |
Primary outcome
Remifentanil consumption (µg/kg/min)
Time frame: During the intraoperative period
1 secondary outcome
Target effective site concentration of remifentanil (ng/ml)
Time frame: After at least 10 min of stable surgical pleth index values
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 15 May 2018.
- Derived from this study: PubMed 30336856Ryu KH, Kim JA, Ko DC, Lee SH, Choi WJ. Desflurane reduces intraoperative remifentanil requirements more than sevoflurane: comparison using surgical pleth index-guided analgesia. Br J Anaesth. 2018 Nov;121(5):1115-1122. doi: 10.1016/j.bja.2018.05.064. Epub 2018 Jul 4.
- 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 15 May 2018. 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?
Remifentanil consumption (µg/kg/min) (time frame: During the intraoperative period). 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 NCT02830243, 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 15 May 2018.