Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery

NCT05474027 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: IRB-300009440
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension During Surgery; Blood Loss, Surgical

Keywords

orthognathic surgery

Outcome Measures

Primary Outcomes (3)

• Surgeon's Analysis of Surgical Field Visualization

  The surgeon will evaluate surgical field visibility using Fromme's ordinal scale

  1 year

• 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.

  1 year

• Estimated Blood Loss

  Volume of blood loss recorded during surgical case

  1 year

Study Arms (1)

Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia

EXPERIMENTAL

Other: Avoidance of Deliberate Hypotensive Anesthesia; Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

Interventions

Avoidance of Deliberate Hypotensive Anesthesia OTHER

The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery.

Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION DRUG

1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.

Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Bimaxillary orthognathic surgery completed at UAB Highlands Hospital

You may not qualify if:

• History of hypertension or previously diagnosed cardiac problems
• Bleeding diathesis
• TXA medically contraindicated

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital-Highlands

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Injections, Intravenous; Solutions

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections; Pharmaceutical Preparations

Study Officials

• Brian Kinard, DMD, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 26, 2022
• Study Start: November 11, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)