ACTIVE_NOT_RECRUITING

Hypotensive Anesthesia for Orthognathic Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall objective of this double blinded, randomized controlled trial (RCT) is to compare specific outcomes of three medications (Dexmedetomidine, Nicardipine, and Labetalol) which are routinely used to lower blood pressure used during general anesthesia for orthognathic (jaw) surgery. The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events. The specific objectives of this study are to compare: 1. Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome) 2. Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss. 3. Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate. 4. Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time. 5. Dexmedetomidine, Nicardipine, and Labetalol's effect on adverse events. The investigators will evaluate healthy adult male and female patients who require jaw surgery at Boston Medical Center. The anticipated 90 participants will be randomized into three groups: ) A Labetalol group in which the patients receive hypotensive anesthesia with the aid of labetalol, 2) A Nicardipine group in which the patients receive hypotensive anesthesia with the aid of nicardipine, and 3) A Dexmedetomidine group in which the patients receive hypotensive anesthesia with the aid of dexmedetomidine. The time it will take for each individual participant ranges from 1-3 months. This time includes the pre-operative visit, the surgical procedure, a 1-week post-operation visit, and then followed for 30 days post-operatively after which the patient's participation in the study will conclude.

Official Title

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

Quick Facts

Study Start:2025-03-04
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06093893

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Healthy, American Society of Anesthesiologists (ASA) physical status classification system I or II
  1. * Patients on a home beta blocker
  2. * Patients on home calcium channel blocker
  3. * Patients on home alpha 2 agonists
  4. * Patients with an allergy to one or more of the intervention medications
  5. * Does not speak English
  6. * Pregnant patients (this is assessed day of surgery per standard care with a urine pregnancy test)
  7. * Patients who have contraindications to induced hypotensive anesthesia

Contacts and Locations

Principal Investigator

Pushkar Mehra, DMD
PRINCIPAL_INVESTIGATOR
Oral and Maxillofacial Surgery Department, Boston Medical Center

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Pushkar Mehra, DMD, PRINCIPAL_INVESTIGATOR, Oral and Maxillofacial Surgery Department, Boston Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-04
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-04
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Dexmedetomidine
  • Nicardipine
  • Labetalol
  • Surgeon visibility
  • Blood loss
  • Hemodynamic parameters
  • Operation time

Additional Relevant MeSH Terms

  • Hypotensive Anesthesia
  • Orthognathic Surgery