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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dexmedetomidine group 		Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
  • Drug: Dexmedetomidine
    1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.
    Other names:
    • Precedex
Experimental
Nicardipine group 		Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
  • Drug: Nicardipine
    1 mg will be administered intravenously and increase by 0.5-1 mg if the initial dose is ineffective, to a maximum of 15 mg / hour or
    Other names:
    • Cardene
Experimental
Labetalol group 		Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.
  • Drug: Labetalol
    20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;
    Other names:
    • Labetalol hydrochloride injection

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Madison Courtney, DDS
617-638-4350
madison.courtney@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Pushkar Mehra, DMD
617-638-4350
pushkar.mehra@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.