Anesthesiologist WorkloadNCT07450794
Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty
An observational study of Anesthesiologist Workload, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to investigate whether the weight-based equivalent (mg/kg) of a fixed 1 g dose of tranexamic acid administered during septorhinoplasty is associated with intraoperative remifentanil titration frequency and perceived anesthesiologist workload. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesiologist Workload
- What is being tested?
- NASA Task Load Index (NASA-TLX)
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2026to 15 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-70 years) undergoing elective septorhinoplasty under general anesthesia at a tertiary academic hospital. All patients receive a fixed 1 g intravenous dose of tranexamic acid as part of routine clinical practice, and intraoperative management includes a controlled hypotension strategy. Consecutive eligible patients with complete perioperative data are included in this prospective observational cohort.
Who may be able to join
- Age ≥ 18 years
- Elective septorhinoplasty under general anesthesia
- Intraoperative administration of fixed 1 g intravenous tranexamic acid as part of routine practice
- Controlled hypotension strategy applied intraoperatively
- Surgery duration between 60-240 minutes
- Complete intraoperative hemodynamic and drug titration records available
Who cannot join
- Emergency surgery
- Additional major surgical procedure performed in the same session
- Known coagulation disorder
- Contraindication to tranexamic acid
- History of thromboembolic disease
- Chronic opioid use or opioid tolerance
Show all 13Show fewer
- Chronic pain syndrome
- Regular use of sedatives, benzodiazepines, or CNS depressants
- Severe cardiac, renal, or hepatic failure
- Uncontrolled hypertension or significant arrhythmia
- Preoperative hemoglobin <10 g/dL
- Major intraoperative complication
- Incomplete or missing intraoperative data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Association Between Weight-Based Equivalent of Fixed 1 g Tranexamic Acid and Intraoperative Remifentanil Titration Frequency and Anesthesiologist Workload in Septorhinoplasty: A Prospective Observational Cohort Study
This prospective observational cohort study aims to investigate whether the weight-based equivalent (mg/kg) of a fixed 1 g dose of tranexamic acid administered during septorhinoplasty is associated with intraoperative remifentanil titration frequency and perceived anesthesiologist workload. Although tranexamic acid is routinely given as a fixed dose, its mg/kg equivalent varies according to patient weight and may influence hemodynamic management during controlled hypotension. The primary outcome is the total number of remifentanil infusion rate adjustments during surgery. Secondary outcomes include total remifentanil consumption and postoperative anesthesiologist workload assessed using the NASA Task Load Index (NASA-TLX).
- Conditions
- Anesthesiologist Workload
- Being tested
- NASA Task Load Index (NASA-TLX)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASA Task Load Index (NASA-TLX)Other
Postoperative assessment of anesthesiologist workload using the NASA Task Load Index (raw scoring method), completed immediately after each operation by the attending anesthesiologist.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Remifentanil Titration Frequency
Total number of intraoperative remifentanil infusion rate adjustments (each increase or decrease counted as one intervention) recorded during septorhinoplasty.
Measured: Intraoperative period (from induction of anesthesia to 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 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion5 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesiologist WorkloadStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450794
- Sponsor's protocol ID
- TXA SRP
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gutierrez RWH, Gobbo HR, Heringer LDFL. Tranexamic Acid in Patients Undergoing Rhinoplasty: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthetic Plast Surg. 2024 Jun;48(11):2076-2085. doi: 10.1007/s00266-023-03768-3. Epub 2023 Dec 14.
PubMed 38097691Yang C, Ji B, Li G, Zhang X, Xu B, Maimaitiming A, Cao L. Weight-based tranexamic acid lowers the risk of postoperative blood loss and transfusion requirements compared with fixed-dose regimen in revision knee arthroplasty: a comparative study. J Orthop Traumatol. 2025 May 2;26(1):26. doi: 10.1186/s10195-025-00844-z.
PubMed 40316735Weber TM Jr, Squier B, Kinard BE. Is Tranexamic Acid Associated With a Reduced Need for Hypotensive Anesthesia During Orthognathic Surgery? J Oral Maxillofac Surg. 2025 Dec;83(12):1470-1477. doi: 10.1016/j.joms.2025.08.013. Epub 2025 Sep 4.
PubMed 40975121Favre-Felix J, Dziadzko M, Bauer C, Duclos A, Lehot JJ, Rimmele T, Lilot M. High-Fidelity Simulation to Assess Task Load Index and Performance: A Prospective Observational Study. Turk J Anaesthesiol Reanim. 2022 Aug;50(4):282-287. doi: 10.5152/TJAR.2022.21234.
PubMed 35979975
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Weight-Based Equivalent of Fixed 1 g Tranexamic Acid and Intraoperative Remifentanil Titration Frequency and Anesthesiologist Workload in Septorhinoplasty: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07450794
- Acronym / sponsor ID
- TXA SRP
- Conditions
- Anesthesiologist Workload
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 5 Mar 2026 (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 prospective observational cohort study aims to investigate whether the weight-based equivalent (mg/kg) of a fixed 1 g dose of tranexamic acid administered during septorhinoplasty is associated with intraoperative remifentanil titration frequency and perceived anesthesiologist workload. Although tranexamic acid is routinely given as a fixed dose, its mg/kg equivalent varies according to patient weight and may influence hemodynamic management during controlled hypotension. The primary outcome is the total number of remifentanil infusion rate adjustments during surgery. Secondary outcomes include total remifentanil consumption and postoperative anesthesiologist workload assessed using the NASA Task Load Index (NASA-TLX).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-70 years) undergoing elective septorhinoplasty under general anesthesia at a tertiary academic hospital. All patients receive a fixed 1 g intravenous dose of tranexamic acid as part of routine clinical practice, and intraoperative management includes a controlled hypotension strategy. Consecutive eligible patients with complete perioperative data are included in this prospective observational cohort.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Elective septorhinoplasty under general anesthesia
- Intraoperative administration of fixed 1 g intravenous tranexamic acid as part of routine practice
- Controlled hypotension strategy applied intraoperatively
- Surgery duration between 60-240 minutes
Key exclusion criteria (13 listed)
- Emergency surgery
- Additional major surgical procedure performed in the same session
- Known coagulation disorder
- Contraindication to tranexamic acid
- History of thromboembolic disease
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 |
|---|---|---|
| NASA Task Load Index (NASA-TLX)Postoperative assessment of anesthesiologist workload using the NASA Task Load Index (raw scoring method), completed immediately after each operation by the attending anesthesiologist. | Other | – |
Primary outcome
Intraoperative Remifentanil Titration Frequency
Time frame: Intraoperative period (from induction of anesthesia to end of surgery).
Total number of intraoperative remifentanil infusion rate adjustments (each increase or decrease counted as one intervention) recorded during septorhinoplasty.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 38097691Gutierrez RWH, Gobbo HR, Heringer LDFL. Tranexamic Acid in Patients Undergoing Rhinoplasty: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthetic Plast Surg. 2024 Jun;48(11):2076-2085. doi: 10.1007/s00266-023-03768-3. Epub 2023 Dec 14.
- Results publication: PubMed 40316735Yang C, Ji B, Li G, Zhang X, Xu B, Maimaitiming A, Cao L. Weight-based tranexamic acid lowers the risk of postoperative blood loss and transfusion requirements compared with fixed-dose regimen in revision knee arthroplasty: a comparative study. J Orthop Traumatol. 2025 May 2;26(1):26. doi: 10.1186/s10195-025-00844-z.
- Results publication: PubMed 40975121Weber TM Jr, Squier B, Kinard BE. Is Tranexamic Acid Associated With a Reduced Need for Hypotensive Anesthesia During Orthognathic Surgery? J Oral Maxillofac Surg. 2025 Dec;83(12):1470-1477. doi: 10.1016/j.joms.2025.08.013. Epub 2025 Sep 4.
- Results publication: PubMed 35979975Favre-Felix J, Dziadzko M, Bauer C, Duclos A, Lehot JJ, Rimmele T, Lilot M. High-Fidelity Simulation to Assess Task Load Index and Performance: A Prospective Observational Study. Turk J Anaesthesiol Reanim. 2022 Aug;50(4):282-287. doi: 10.5152/TJAR.2022.21234.
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.
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 Anesthesiologist Workload, run by Istinye 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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 5 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Remifentanil Titration Frequency (time frame: Intraoperative period (from induction of anesthesia to end of surgery).). 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 NCT07450794, which also lists 4 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 5 Mar 2026.