TympanoplastyANFLUXNCT07064642
NLR and Sevoflurane Use in Ear Surgeries: Flow Comparison
An observational study of Tympanoplasty and Myringoplasty, run by Eda KAZANÇ ÖZDEN at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study aims to compare the effects of low-flow and high-flow anesthesia techniques on intraoperative hemodynamics, neutrophil-to-lymphocyte ratio (NLR), and postoperative outcomes in patients undergoing tympanoplasty or myringoplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tympanoplasty, Myringoplasty, Neutrophil-to-Lymphocyte Ratio
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 20 Sep 2023
- Phase
- Observational
- 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
Study population: This retrospective study evaluated patients who underwent tympanoplasty or myringoplasty surgery at the operating rooms of Karadeniz Technical University Faculty of Medicine between September 1, 2022, and April 1, 2023. Participants were excluded based on the following criteria: age under 18 or over 75 years, incomplete clinical data, body mass index (BMI) <18.5 kg/m² or >29.9 kg/m², presence of neurological disorders, and a history of renal or hepatic failure. A total of 59 patients aged between 18 and 75 years, with ASA (American Society of Anesthesiologists) physical status scores of I-III and BMI values between 18.5 and 29.9 kg/m², were initially included in the study. Following the exclusion of nine patients with missing data, the final study population consisted of 50 individuals.
Who may be able to join
- Adults aged between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
Who cannot join
- Age below 18 or above 75 years
- Incomplete or missing clinical data
- BMI less than 18.5 kg/m² or greater than 29.9 kg/m²
- Presence of neurological disorders
- History of renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Faculty of Medicine Hospital
Trabzon, Trabzon, 61080
About this study
Official title: A Retrospective Comparison Of The Effects Of Low-Flow And High-Flow Anesthesia On Hemodynamics, Neutrophil-To-Lymphocyte Ratio, And Postoperative Outcomes In Tympanoplasty And Myringoplasty Surgeries
This retrospective study aims to compare the effects of low-flow and high-flow anesthesia techniques on intraoperative hemodynamics, neutrophil-to-lymphocyte ratio (NLR), and postoperative outcomes in patients undergoing tympanoplasty or myringoplasty. The data were collected from medical records of patients who underwent ear surgery between [September 1, 2022] and [April 1, 2023]. The study seeks to evaluate whether the choice of anesthetic flow rate has a significant impact on inflammatory response and recovery.
Read the detailed description
This study investigates the influence of anesthetic gas flow rates on systemic inflammation and hemodynamic stability in middle ear surgeries. While low-flow anesthesia is associated with reduced environmental exposure and cost-effectiveness, its impact on inflammatory markers and recovery outcomes remains less clearly defined. The neutrophil-to-lymphocyte ratio (NLR) is used as a readily available, cost-effective biomarker of systemic inflammation. This study retrospectively analyzes perioperative data from patients who underwent tympanoplasty or myringoplasty, comparing NLR levels, intraoperative vital signs, and postoperative recovery parameters between low-flow and high-flow anesthesia groups. The results may contribute to optimizing anesthetic strategies in otologic surgeries, with emphasis on inflammation modulation and patient safety.
- Conditions
- Tympanoplasty, Myringoplasty, Neutrophil-to-Lymphocyte Ratio, Low-flow Anesthesia, High-flow Anesthesia
- Keywords
- Anesthesia high-flow, Anesthesia low-flow, Neutrophil-lymphocyte ratio, Systemic inflammatory response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low-flow anesthesia group | Low-flow anesthesia group 0.75 L/min : Patients who underwent tympanoplasty or myringoplasty under low-flow anesthesia technique. The anesthetic gas flow rate was maintained at low levels throughout the procedure to evaluate its effects on systemic inflammation and hemodynamics. | |
| High-flow anesthesia group | High-flow anesthesia group 3 L/min : Patients who underwent tympanoplasty or myringoplasty under high-flow anesthesia technique. The anesthetic gas flow rate was maintained at high levels throughout the procedure to compare its impact on inflammatory response and postoperative outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative neutrophil-to-lymphocyte ratio (NLR)
The neutrophil-to-lymphocyte ratio measured from blood samples taken immediately after surgery to assess the systemic inflammatory response in patients undergoing tympanoplasty or myringoplasty with low-flow or high-flow anesthesia.
Measured: Within 1 hour postoperatively (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start20 Jul 2023
- Primary completion20 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TympanoplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eda KAZANÇ ÖZDEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eda KAZANÇ ÖZDEN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064642
- Sponsor's protocol ID
- EKO-NLR-2025
- Other IDs
- 2023/122
- Acronym
- ANFLUX
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparison Of The Effects Of Low-Flow And High-Flow Anesthesia On Hemodynamics, Neutrophil-To-Lymphocyte Ratio, And Postoperative Outcomes In Tympanoplasty And Myringoplasty Surgeries
- ClinicalTrials.gov ID
- NCT07064642
- Acronym / sponsor ID
- ANFLUX / EKO-NLR-2025
- Conditions
- Tympanoplasty, Myringoplasty, Neutrophil-to-Lymphocyte Ratio, Low-flow Anesthesia, High-flow Anesthesia
- Keywords
- Anesthesia high-flow, Anesthesia low-flow, Neutrophil-lymphocyte ratio, Systemic inflammatory response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eda KAZANÇ ÖZDENUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 15 Jul 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 retrospective study aims to compare the effects of low-flow and high-flow anesthesia techniques on intraoperative hemodynamics, neutrophil-to-lymphocyte ratio (NLR), and postoperative outcomes in patients undergoing tympanoplasty or myringoplasty. The data were collected from medical records of patients who underwent ear surgery between [September 1, 2022] and [April 1, 2023]. The study seeks to evaluate whether the choice of anesthetic flow rate has a significant impact on inflammatory response and recovery.
Detailed description
This study investigates the influence of anesthetic gas flow rates on systemic inflammation and hemodynamic stability in middle ear surgeries. While low-flow anesthesia is associated with reduced environmental exposure and cost-effectiveness, its impact on inflammatory markers and recovery outcomes remains less clearly defined. The neutrophil-to-lymphocyte ratio (NLR) is used as a readily available, cost-effective biomarker of systemic inflammation. This study retrospectively analyzes perioperative data from patients who underwent tympanoplasty or myringoplasty, comparing NLR levels, intraoperative vital signs, and postoperative recovery parameters between low-flow and high-flow anesthesia groups. The results may contribute to optimizing anesthetic strategies in otologic surgeries, with emphasis on inflammation modulation and patient safety.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-flow anesthesia group | – | –Low-flow anesthesia group 0.75 L/min : Patients who underwent tympanoplasty or myringoplasty under low-flow anesthesia technique. The anesthetic gas flow rate was maintained at low levels throughout the procedure to evaluate its effects on systemic inflammation and hemodynamics. |
| High-flow anesthesia group | – | –High-flow anesthesia group 3 L/min : Patients who underwent tympanoplasty or myringoplasty under high-flow anesthesia technique. The anesthetic gas flow rate was maintained at high levels throughout the procedure to compare its impact on inflammatory response and postoperative outcomes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study evaluated patients who underwent tympanoplasty or myringoplasty surgery at the operating rooms of Karadeniz Technical University Faculty of Medicine between September 1, 2022, and April 1, 2023. Participants were excluded based on the following criteria: age under 18 or over 75 years, incomplete clinical data, body mass index (BMI) <18.5 kg/m² or >29.9 kg/m², presence of neurological disorders, and a history of renal or hepatic failure. A total of 59 patients aged between 18 and 75 years, with ASA (American Society of Anesthesiologists) physical status scores of I-III and BMI values between 18.5 and 29.9 kg/m², were initially included in the study. Following the exclusion of nine patients with missing data, the final study population consisted of 50 individuals.
Key inclusion criteria (3 listed)
- Adults aged between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status classification I to III
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
Key exclusion criteria (5 listed)
- Age below 18 or above 75 years
- Incomplete or missing clinical data
- BMI less than 18.5 kg/m² or greater than 29.9 kg/m²
- Presence of neurological disorders
- History of renal or hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative neutrophil-to-lymphocyte ratio (NLR)
Time frame: Within 1 hour postoperatively (Day 0)
The neutrophil-to-lymphocyte ratio measured from blood samples taken immediately after surgery to assess the systemic inflammatory response in patients undergoing tympanoplasty or myringoplasty with low-flow or high-flow 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 17 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanoplasty and Myringoplasty, run by Eda KAZANÇ ÖZDEN 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 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 17 Jul 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?
Postoperative neutrophil-to-lymphocyte ratio (NLR) (time frame: Within 1 hour postoperatively (Day 0)). 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 17 Jul 2025.