Comparing medications for blood pressure control during jaw surgery
A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Surgeon Visibility, Blood Loss, Hemodynamic Parameters, Operation Time, and Adverse Events During Orthognathic Surgery
This study tests which of three blood pressure medications works best during jaw surgery to help both patients and surgeons.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06093893 on ClinicalTrials.gov |
What this trial studies
This double-blinded, randomized controlled trial aims to evaluate the effectiveness of three medications—Dexmedetomidine, Nicardipine, and Labetalol—in managing blood pressure during orthognathic surgery. The study will assess various outcomes, including surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and any adverse events. By comparing these medications, the trial seeks to determine which provides the best conditions for surgeons and patients alike during these procedures.
Who should consider this trial
Good fit: Ideal candidates are adult patients undergoing specific types of orthognathic surgery at Boston Medical Center who are classified as ASA physical status I or II.
Not a fit: Patients on beta blockers, calcium channel blockers, or alpha 2 agonists, as well as those with allergies to the study medications, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and patient safety during orthognathic surgeries by identifying the most effective medication for blood pressure control.
How similar studies have performed: Other studies have shown promising results with similar approaches to hypotensive anesthesia, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients undergoing orthognathic surgery \[Le Fort I, Surgically Assisted Rapid Palatal Expansion (SARPE), Bilateral Sagittal Split Osteotomy (BSSO), or a combination these surgeries\] at Boston Medical Center with Dr. Mehra * Healthy, American Society of Anesthesiologists (ASA) physical status classification system I or II Exclusion Criteria: * Patients on a home beta blocker * Patients on home calcium channel blocker * Patients on home alpha 2 agonists * Patients with an allergy to one or more of the intervention medications * Does not speak English * Pregnant patients (this is assessed day of surgery per standard care with a urine pregnancy test) * Patients who have contraindications to induced hypotensive anesthesia
Where this trial is running
Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Pushkar Mehra, DMD — Oral and Maxillofacial Surgery Department, Boston Medical Center
- Study coordinator: Pushkar Mehra, DMD
- Email: pushkar.mehra@bmc.org
- Phone: 617-638-4350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.