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Search / Trial NCT06093893

Hypotensive Anesthesia for Orthognathic Surgery

Launched by BOSTON MEDICAL CENTER · Oct 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Dexmedetomidine Nicardipine Labetalol Surgeon Visibility Blood Loss Hemodynamic Parameters Operation Time

ClinConnect Summary

This clinical trial is studying how three different medications—Dexmedetomidine, Nicardipine, and Labetalol—affect patients undergoing jaw surgery, specifically looking at how well they lower blood pressure during anesthesia. The goal is to see which medication helps provide a clearer view for surgeons, reduces blood loss, and affects operation time and patient safety the best. The trial will involve healthy adults needing specific types of jaw surgery at Boston Medical Center.

To participate, you must be an adult patient scheduled for jaw surgery and in good health. However, if you're on certain heart medications or have allergies to any of the trial drugs, you won't be eligible. Participants will go through a pre-operative visit, have their surgery, and then attend a follow-up appointment a week later, with additional check-ins for 30 days after surgery. Overall, involvement in the study will last between one to three months. This trial aims to ensure safer and more effective anesthesia practices for jaw surgeries.

Gender

ALL

Eligibility 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

About Boston Medical Center

Boston Medical Center (BMC) is a leading academic medical center located in Boston, Massachusetts, dedicated to providing high-quality, compassionate care to diverse populations. As a prominent clinical trial sponsor, BMC conducts innovative research aimed at advancing medical knowledge and improving patient outcomes across a wide range of specialties. With a commitment to health equity and access to care, BMC collaborates with various stakeholders, including academic institutions and industry partners, to facilitate groundbreaking studies and translate findings into effective treatments. Its robust infrastructure and experienced research teams ensure adherence to the highest ethical standards and regulatory compliance in all clinical trials.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Pushkar Mehra, DMD

Principal Investigator

Oral and Maxillofacial Surgery Department, Boston Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported