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

NCT ID: NCT06301204

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-11-01

Brief Summary

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.

Detailed Description

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.

Conditions

Tranexamic Acid; Orthognathic Surgery; Edema; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

control group

control group patient give no drug administration during bimaxillary orthognathic surgery.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

onyl ıv saline (NaCl 0.09%)

group 1(intravenous administration of 250 mg tranexamic acid)

group 1 (TRANEXEL 250 mg/5 mL) patients administered 250 mg tnx acid during the whole bimaxillary orthognathic surgery

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

tranexamic acid administration 250mg or 500 mg

group 2 (intravenous administration of 500 mg tranexamic acid)

group 2 (TRANEXEL 250 mg/5 mL) patients administered 500 mg tnx acid during the whole surgery.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

tranexamic acid administration 250mg or 500 mg

Interventions

Tranexamic acid injection

tranexamic acid administration 250mg or 500 mg

Intervention Type: DRUG

Saline

onyl ıv saline (NaCl 0.09%)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with class 2 or class 3 dentofacial malformation who are planned to undergo bimaxillary orthognathic surgery.

2. Patients who have not had orthognathic surgery before

3. Patients without cleft lip and palate

4. Patients without systemic bleeding diets

Exclusion Criteria

1. Having a systemic disease that affects general health status

2. Presence of a malignant disease in the head and neck region

3. Patients who have previously undergone orthognathic surgery

4. Patients with any bleeding disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bezmialem Vakıf Universty

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

21.06.2022-E.67046

Identifier Type: -

Identifier Source: org_study_id