Low Flow AnesthesiaNCT06810453
The Effects of Sevoflurane and Desflurane Used in Low-Flow Anesthesia on Thiol Disulfide Homeostasis
A study testing A 5 cc venous blood sample was obtained and low-flow anesthesia in people with Low Flow Anesthesia, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effects of sevoflurane and desflurane used in low-flow anesthesia on thiol-disulfide homeostasis of patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Flow Anesthesia
- What is being tested?
- A 5 cc venous blood sample was obtained and low-flow anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Jan 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled to undergo elective total thyroidectomy under general anesthesia
Who cannot join
- Patients with diabetes mellitus, alcohol or drug addiction, smoking habits, expected difficult intubation, morbid obesity, chronic obstructive pulmonary disease, cardiovascular disease and those in pregnancy or lactation period were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of End-tidal Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries
This study aimed to compare the effects of sevoflurane and desflurane used in low-flow anesthesia on thiol-disulfide homeostasis of patients undergoing general anesthesia.
Read the detailed description
Fifty patients were included who were scheduled to undergo elective total thyroidectomy operation under general anesthesia. The patients were assigned to one of 2 groups. Group S was the low-flow sevoflurane anesthesia group and Group D was the low-flow desflurane group. Blood samples were collected to evaluate thiol disulfide homeostasis preoperatively and postoperatively.
- Conditions
- Low Flow Anesthesia
- Being tested
- A 5 cc venous blood sample was obtained, low-flow anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 5 cc venous blood sample was obtainedOther
A 5 cc venous blood sample was obtained just before anesthesia induction and at the end of surgery.
low-flow anesthesiaProcedure or surgery
Low-flow anesthesia, also known as inhalational anesthesia method, is a type of anesthesia that is performed using a semi-closed, rebreathing system containing at least 50% fresh gas. Generally, low-flow anesthesia is used in anesthesia practices because it reduces costs, prevents environmental pollution, increases the humidity of gases, and reduces heat loss. Another important benefit of low-flow is that it requires closer monitoring of patients, which allows for early detection of complications during general anesthesia, thus improving patient safety. Concerns about low-flow anesthesia being used infrequently in the past have been addressed by the introduction of modern anesthesia workstations with sophisticated monitoring and safety features, which have made low-flow anesthesia widely used in most centers.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Other | sevoflurane low-flow anesthesia Receives: Other: A 5 cc venous blood sample was obtained; Procedure: low-flow anesthesia |
| desflurane | Other | desflurane low-flow anesthesia Receives: Other: A 5 cc venous blood sample was obtained; Procedure: low-flow anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum thiol-disulfide homeostasis parameters measurement/ calculation
Serum thiol-disulfide homeostasis parameters were evaluated using an automated method (3). Homeostasis parameters include disulfide, native thiol (NT) and total thiol (TT) levels, and disulfide/TT, NT/TT, and disulfide/NT ratios. TT and NT levels were measured in μmol/L on a Beckman Coulter AU480 analyzer using a commercial kits (Rel Assay Diagnostics, Türkiye). The amount of disulfide was calculated using the formula ((TT-NT) /2). Then, ratios were calculated as percentages
Measured: A 5 cc venous blood sample was obtained just before the anesthesia induction and at the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Sep 2020
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Flow 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem SEN, University of Gaziantep
- Investigators
- Elzem Sen, Assoc Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810453
- Sponsor's protocol ID
- 2020/283
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of End-tidal Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries
- ClinicalTrials.gov ID
- NCT06810453
- Acronym / sponsor ID
- 2020/283
- Conditions
- Low Flow Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 5 Feb 2025 (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.
This study aimed to compare the effects of sevoflurane and desflurane used in low-flow anesthesia on thiol-disulfide homeostasis of patients undergoing general anesthesia.
Detailed description
Fifty patients were included who were scheduled to undergo elective total thyroidectomy operation under general anesthesia. The patients were assigned to one of 2 groups. Group S was the low-flow sevoflurane anesthesia group and Group D was the low-flow desflurane group. Blood samples were collected to evaluate thiol disulfide homeostasis preoperatively and postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Other | Other: A 5 cc venous blood sample was obtained, Procedure: low-flow anesthesiasevoflurane low-flow anesthesia |
| desflurane | Other | Other: A 5 cc venous blood sample was obtained, Procedure: low-flow anesthesiadesflurane low-flow anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were scheduled to undergo elective total thyroidectomy under general anesthesia
Key exclusion criteria (1 listed)
- Patients with diabetes mellitus, alcohol or drug addiction, smoking habits, expected difficult intubation, morbid obesity, chronic obstructive pulmonary disease, cardiovascular disease and those in pregnancy or lactation period were excluded from the study.
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 |
|---|---|---|
| A 5 cc venous blood sample was obtainedA 5 cc venous blood sample was obtained just before anesthesia induction and at the end of surgery. | Other | desflurane, sevoflurane |
| low-flow anesthesiaLow-flow anesthesia, also known as inhalational anesthesia method, is a type of anesthesia that is performed using a semi-closed, rebreathing system containing at least 50% fresh gas. Generally, low-flow anesthesia is used in anesthesia practices because it reduces costs, prevents environmental pollution, increases the humidity of gases, and reduces heat loss. Another important benefit of low-flow is that it requires closer monitoring of patients, which allows for early detection of complications during general anesthesia, thus improving patient safety. Concerns about low-flow anesthesia being used infrequently in the past have been addressed by the introduction of modern anesthesia workstations with sophisticated monitoring and safety features, which have made low-flow anesthesia widely used in most centers. | Procedure or surgery | desflurane, sevoflurane |
Primary outcome
Serum thiol-disulfide homeostasis parameters measurement/ calculation
Time frame: A 5 cc venous blood sample was obtained just before the anesthesia induction and at the end of surgery.
Serum thiol-disulfide homeostasis parameters were evaluated using an automated method (3). Homeostasis parameters include disulfide, native thiol (NT) and total thiol (TT) levels, and disulfide/TT, NT/TT, and disulfide/NT ratios. TT and NT levels were measured in μmol/L on a Beckman Coulter AU480 analyzer using a commercial kits (Rel Assay Diagnostics, Türkiye). The amount of disulfide was calculated using the formula ((TT-NT) /2). Then, ratios were calculated as percentages
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 5 Feb 2025.
- Individual participant dataSharing planned: No
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Anesthesia
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.
Elzem Sen, Assoc Prof principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 5 cc venous blood sample was obtained and low-flow anesthesia in people with Low Flow Anesthesia, run by University of Gaziantep 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 1 inclusion and 1 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 5 Feb 2025. 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.
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?
Serum thiol-disulfide homeostasis parameters measurement/ calculation (time frame: A 5 cc venous blood sample was obtained just before the anesthesia induction and at the end of surgery.). 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 5 Feb 2025.