AnesthesiaPhase 4NCT05024084
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth
A Phase 4 study testing Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane and Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane in people with Anesthesia, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Minimal flow anesthesia has economic and environmental advantages in addition to providing earlier recovery following general anesthesia. There is a paucity of data concerning the effect of minimal flow anesthesia (fresh gas flow <0,5 l/min) on recovery parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane and Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2021to 1 Oct 2021
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 65
- Patients undergoing elective surgery under general anesthesia
- Patients with an American Society of Anesthesiologists Classification I or II
Who cannot join
- Patient refusal
- Emergency surgery
- Patients with a contraindication for minimal flow anesthesia
- Uncontrolled diabetes mellitus
- History of serious systemic disease (cardiac, pulmonary, hepatic)
- Utilization of another analgesic technique such as central or peripheral nerve blocks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ufuk University Dr. Rıdvan Ege Hospital
Ankara, 06520
Baturay K Kazbek, Ass. Prof., +903122044000 ext. 4099, bkkazbek@gmail.com
About this study
Official title: Comparison of Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery Parameters and Anesthetic Depth: a Randomized Prospective Study
Minimal flow anesthesia has economic and environmental advantages in addition to providing earlier recovery following general anesthesia. There is a paucity of data concerning the effect of minimal flow anesthesia (fresh gas flow <0,5 l/min) on recovery parameters. The primary objective of this study is to compare the recovery parameters of desflurane and sevoflurane in minimal flow anesthesia while the secondary objective is to compare the effect of these agents on anesthetic depth using bispectral index.
- Conditions
- Anesthesia
- Being tested
- Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane, Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane
- Keywords
- general anesthesia, low flow anesthesia, sevoflurane, desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal flow anesthesia (fresh gas flow <0.5 l/min) using SevofluraneProcedure or surgery
Sevoflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min
Minimal flow anesthesia (fresh gas flow <0.5 l/min) using DesfluraneProcedure or surgery
Desflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min
| Study group | Role | What they receive |
|---|---|---|
| Group Sevoflurane | Active comparator | The patients in this arm will be given Sevoflurane (2-3%) as volatile anesthetic throughout the duration of anesthesia. Receives: Procedure: Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane |
| Group Desflurane | Active comparator | The patients in this arm will be given Desflurane (7-8%) as volatile anesthetic throughout the duration of anesthesia. Receives: Procedure: Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until extubation
Time interval between discontinuation of the volatile anesthetics and removal of the endotracheal tube
Measured: Up to 10 minutes after discontinuation of the volatile anesthetic
Time until eye opening
Time interval between discontinuation of the volatile anesthetics and eye opening with verbal command
Measured: Up to 20 minutes after discontinuation of the volatile anesthetic
Time until transfer readiness
Time interval between discontinuation of the volatile anesthetics and Aldrete score reaching 9 or greater
Measured: Up to 45 minutes after discontinuation of the volatile anesthetic
Secondary outcomes (1)
Anesthetic depth provided by the volatile anesthetic
Anesthetic depth as measured by Bispectral Index
Measured: Change in Bispectral Index values at 5, 10, 15, 30, 60 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start5 Sep 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baturay Kansu Kazbek, Ufuk University
- Investigators
- Baturay K Kazbek, Ass. Prof., Principal investigator, Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024084
- Sponsor's protocol ID
- 2021-009
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taskin D, Gedik E, Kayhan Z. Effects of Minimal Flow Sevoflurane or Desflurane Anaesthesia on Hemodynamic Parameters, Body Temperature and Anaesthetic Consumption. Turk J Anaesthesiol Reanim. 2020 Oct;48(5):356-363. doi: 10.5152/TJAR.2020.39699. Epub 2020 May 5.
PubMed 33103139Werner JG, Castellon-Larios K, Thongrong C, Knudsen BE, Lowery DS, Antor MA, Bergese SD. Desflurane Allows for a Faster Emergence When Compared to Sevoflurane without Affecting the Baseline Cognitive Recovery Time. Front Med (Lausanne). 2015 Oct 28;2:75. doi: 10.3389/fmed.2015.00075. eCollection 2015.
PubMed 26579522
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery Parameters and Anesthetic Depth: a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT05024084
- Acronym / sponsor ID
- 2021-009
- Conditions
- Anesthesia
- Keywords
- general anesthesia, low flow anesthesia, sevoflurane, desflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 27 Aug 2021 (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.
Minimal flow anesthesia has economic and environmental advantages in addition to providing earlier recovery following general anesthesia. There is a paucity of data concerning the effect of minimal flow anesthesia (fresh gas flow <0,5 l/min) on recovery parameters. The primary objective of this study is to compare the recovery parameters of desflurane and sevoflurane in minimal flow anesthesia while the secondary objective is to compare the effect of these agents on anesthetic depth using bispectral index.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Sevoflurane | Active comparator | Procedure: Minimal flow anesthesia (fresh gas flow <0.5 l/min) using SevofluraneThe patients in this arm will be given Sevoflurane (2-3%) as volatile anesthetic throughout the duration of anesthesia. |
| Group Desflurane | Active comparator | Procedure: Minimal flow anesthesia (fresh gas flow <0.5 l/min) using DesfluraneThe patients in this arm will be given Desflurane (7-8%) as volatile anesthetic throughout the duration of anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 18 and 65
- Patients undergoing elective surgery under general anesthesia
- Patients with an American Society of Anesthesiologists Classification I or II
Key exclusion criteria (6 listed)
- Patient refusal
- Emergency surgery
- Patients with a contraindication for minimal flow anesthesia
- Uncontrolled diabetes mellitus
- History of serious systemic disease (cardiac, pulmonary, hepatic)
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 |
|---|---|---|
| Minimal flow anesthesia (fresh gas flow <0.5 l/min) using SevofluraneSevoflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min | Procedure or surgery | Group Sevoflurane |
| Minimal flow anesthesia (fresh gas flow <0.5 l/min) using DesfluraneDesflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min | Procedure or surgery | Group Desflurane |
Primary outcome
Time until extubation
Time frame: Up to 10 minutes after discontinuation of the volatile anesthetic
Time interval between discontinuation of the volatile anesthetics and removal of the endotracheal tube
Time until eye opening
Time frame: Up to 20 minutes after discontinuation of the volatile anesthetic
Time interval between discontinuation of the volatile anesthetics and eye opening with verbal command
Time until transfer readiness
Time frame: Up to 45 minutes after discontinuation of the volatile anesthetic
Time interval between discontinuation of the volatile anesthetics and Aldrete score reaching 9 or greater
1 secondary outcome
Anesthetic depth provided by the volatile anesthetic
Time frame: Change in Bispectral Index values at 5, 10, 15, 30, 60 and 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Background: PubMed 33103139Taskin D, Gedik E, Kayhan Z. Effects of Minimal Flow Sevoflurane or Desflurane Anaesthesia on Hemodynamic Parameters, Body Temperature and Anaesthetic Consumption. Turk J Anaesthesiol Reanim. 2020 Oct;48(5):356-363. doi: 10.5152/TJAR.2020.39699. Epub 2020 May 5.
- Background: PubMed 26579522Werner JG, Castellon-Larios K, Thongrong C, Knudsen BE, Lowery DS, Antor MA, Bergese SD. Desflurane Allows for a Faster Emergence When Compared to Sevoflurane without Affecting the Baseline Cognitive Recovery Time. Front Med (Lausanne). 2015 Oct 28;2:75. doi: 10.3389/fmed.2015.00075. eCollection 2015.
- 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.
Baturay K Kazbek, Ass. Prof. principal investigator
Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane and Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane in people with Anesthesia, run by Ufuk University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baturay K Kazbek, Ass. Prof. (+903122044000 ext. 4099, bkkazbek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until extubation (time frame: Up to 10 minutes after discontinuation of the volatile anesthetic). The study lists 3 primary outcomes in all. 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 NCT05024084, which also lists 2 linked publications.
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 20 Sep 2021.