Clinical trial NCT05474027: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Hypotension During Surgery
Blood Loss, Surgical
Keywords: orthognathic surgery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Surgeon's Analysis of Surgical Field Visualization
timeFrame: 1 year
measure: Mean Arterial Pressure
timeFrame: 1 year
measure: Estimated Blood Loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital-Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Brian Kinard, DMD, MD
role: PRINCIPAL_INVESTIGATOR
References: