Clinical trial NCT06301204: Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients
Official title: Evaluation Of The Effectiveness Of Tranexamic Acid Application Protocol With Different Doses On Bleeding, Edema And Physician Comfort In Bimaxillary Orthognathic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tranexamic Acid
Orthognathic Surgery
Edema
Bleeding
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: intraoperative bleeding during the surgery (ml)
timeFrame: during the operation time (hour)
Secondary outcomes:
measure: postoperative edema calculation for the first 1-3 and 7 day (cm)
timeFrame: post operative 1-3-7 days
measure: intraoperative surgical site evaluation (Fromme Scale)
timeFrame: during the surgical time (hour)
measure: Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day
timeFrame: during the preoperative and post operative 2. day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Universty
state: Fatih
Study officials:
References: