Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
Primary Purpose
Hypotension During Surgery, Blood Loss, Surgical
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Avoidance of Deliberate Hypotensive Anesthesia
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
Sponsored by
About this trial
This is an interventional other trial for Hypotension During Surgery focused on measuring orthognathic surgery
Eligibility Criteria
Inclusion Criteria:
- Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
Exclusion Criteria:
- History of hypertension or previously diagnosed cardiac problems
- Bleeding diathesis
- TXA medically contraindicated
Sites / Locations
- UAB Hospital-Highlands
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia
Arm Description
Outcomes
Primary Outcome Measures
Surgeon's Analysis of Surgical Field Visualization
The surgeon will evaluate surgical field visibility using Fromme's ordinal scale
Mean Arterial Pressure
Tracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Estimated Blood Loss
Volume of blood loss recorded during surgical case
Secondary Outcome Measures
Full Information
NCT ID
NCT05474027
First Posted
July 20, 2022
Last Updated
December 16, 2022
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05474027
Brief Title
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
Official Title
Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.
Detailed Description
Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. Patients will be evaluated for the following variables: sex, age, weight at time of surgery, preoperative hemoglobin, and preoperative hematocrit. Patients will be included if they are undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. All patients treated with orthognathic surgery already are provided 1g of TXA perioperatively and this will be continued through this study. All patients will be treated with 1g of TXA perioperatively and the anesthesia team will be instructed to limit deliberate hypotensive anesthesia unless otherwise directed by the surgeon. Perioperative and post-operative measurements will include: estimated blood loss, pre and post-operative hemoglobin, pre and post-operative hematocrit, average mean arterial pressure throughout the case (MAP), maximum MAP (excluding induction and emergence), minimum MAP (excluding induction and emergence), total MAP time under 65 mmHg, length of procedure, and surgeon evaluation of visual field throughout the procedure utilizing Fromme's ordinal scale. Based on these factors, it will help determine the need for deliberate hypotensive anesthesia during orthognathic surgery when tranexamic acid is administered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension During Surgery, Blood Loss, Surgical
Keywords
orthognathic surgery
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. 1g of tranexamic acid will be given perioperatively as already routinely performed. The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to patient baseline.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Avoidance of Deliberate Hypotensive Anesthesia
Intervention Description
The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery.
Intervention Type
Drug
Intervention Name(s)
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
Intervention Description
1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.
Primary Outcome Measure Information:
Title
Surgeon's Analysis of Surgical Field Visualization
Description
The surgeon will evaluate surgical field visibility using Fromme's ordinal scale
Time Frame
1 year
Title
Mean Arterial Pressure
Description
Tracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Time Frame
1 year
Title
Estimated Blood Loss
Description
Volume of blood loss recorded during surgical case
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
Exclusion Criteria:
History of hypertension or previously diagnosed cardiac problems
Bleeding diathesis
TXA medically contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kinard, DMD, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Hospital-Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
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