Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty

March 1, 2026 updated by: İlke Dolgun, Istinye University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative period (from induction of anesthesia to end of surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 5, 2026

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TXA SRP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesiologist Workload

Clinical Trials on NASA Task Load Index (NASA-TLX)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe