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Completed

NCT Number: NCT06301204

Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients

The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf Universty

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

This prospective double blind clinical study was approved by the Bezmialem Vakif University Clinical Research Ethics Committee (2022-E.6706). All patients were provided detailed explanations of the surgical procedure and potential adverse events, underwent preoperative anesthesia assessments, and provided informed consent. A total of 60 patients were included in the study and were randomly assigned to three groups: Study Group 1 (N=20), Study Group 2 (N=20), and Control Group (N=20). In Study Group 1, patients received local anesthesia prior to bimaxillary osteotomy, followed by intravenous administration of 250 mg / 2.5 mL tranexamic acid before starting with the incision. In Study Group 2, patients also received local anesthesia before bimaxillary osteotomy, followed by intravenous administration of 250 mg / 2.5 mL tranexamic acid for le fort 1 and, a second dose of 250 mg / 2.5 mL tranexamic acid was administered for beginning of the sagittal split osteotomy. The Control Group, Group 3, did not receive any medication before or after surgery. All patients underwent bimaxillary surgery using the same surgical technique and same surgical team.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with class 2 or class 3 dentofacial malformation who are planned to undergo bimaxillary orthognathic surgery.
  • Patients who have not had orthognathic surgery before
  • Patients without cleft lip and palate
  • Patients without systemic bleeding diets

Exclusion criteria

  • Having a systemic disease that affects general health status
  • Presence of a malignant disease in the head and neck region
  • Patients who have previously undergone orthognathic surgery
  • Patients with any bleeding disorders

Treatment and study plan

Tranexamic acid injection

Drug

tranexamic acid administration 250mg or 500 mg

Saline

Drug

onyl ıv saline (NaCl 0.09%)

Primary outcomes

  1. intraoperative bleeding during the surgery (ml)

    Time frame: during the operation time (hour)

    the primary outcome is this study is assessment of the intraoperative bleeding: Intraoperative bleeding will be calculated by subtracting the total amount of iv fluid and the amount of irrigation solutions used during surgery from the total amount of aspirate volume.

Secondary outcomes

  1. postoperative edema calculation for the first 1-3 and 7 day (cm)

    Time frame: post operative 1-3-7 days

    the first secondary outcome of this study is post operative edema: Prior to anesthesia induction, Tragus (Tra) and Gonion (Go) points were marked with methylene blue, and distances including Lateral Canthus - Gonion, Tragus-Commissure, and interincisal distances were measured with a paper ruler and recorded as preoperative measurements.Measurements of Lateral Canthus - Gonion, Tragus-Commissure, and Interincisal distances were repeated on postoperative days 1, 3, and 7 for evaluating postoperative edema.

  2. intraoperative surgical site evaluation (Fromme Scale)

    Time frame: during the surgical time (hour)

    the second secondary outcome is surgical site evaluation during the surgery. Surgeon evaluate the surgical site according to Fromme Scale per every one hour.

    0 = No bleeding, virtually bloodless field

    • = Bleeding so mild it is not even a surgical nuisance
    • = Moderate bleeding, a nuisance but without interference with accurate dissection
    • = Moderate bleeding that moderately compromises surgical dissection
    • = Heavy but controllable that significantly interferes with dissection
    • = Massive uncontrollable bleeding
  3. Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day

    Time frame: during the preoperative and post operative 2. day

    Hemoglobin (Hgb) and Hematocrit (Hct) values were recorded preoperatively and second postoperative day.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Evaluation Of The Effectiveness Of Tranexamic Acid Application Protocol With Different Doses On Bleeding, Edema And Physician Comfort In Bimaxillary Orthognathic Surgery Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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