Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301204
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-02-13
Brief Title:
Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding Edema And Physician Comfort In Orthognathıc Surgery Patients
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg and 2 ampoules IV approximately 6 mgkg 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-E6706 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 N20 Study Group 2 N20 and Control Group N20 In Study Group 1 patients received local anesthesia prior to bimaxillary osteotomy followed by intravenous administration of 250 mg 25 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 25 mL tranexamic acid for le fort 1 and a second dose of 250 mg 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None