Hypotensive Anesthesia for Jaw Surgery

Recruiting in Palo Alto (17 mi)

Overseen byPushkar Mehra, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Boston Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for healthy adults needing jaw surgery at Boston Medical Center, with no home use of beta blockers, calcium channel blockers, or alpha 2 agonists. Participants must not be allergic to the study drugs, should speak English and cannot be pregnant.

Inclusion Criteria

I am generally healthy with minimal or mild systemic disease.

I am an adult scheduled for jaw surgery at Boston Medical Center with Dr. Mehra.

Exclusion Criteria

I do not speak English.

I am taking calcium channel blocker medication at home.

I am taking alpha 2 agonists at home.

+3 more

Participant Groups

The trial compares three blood pressure-lowering medications—Dexmedetomidine, Nicardipine, and Labetalol—used during anesthesia in jaw surgery. It's a double-blinded RCT where patients are randomly assigned to one of the three drug groups.

3Treatment groups

Experimental Treatment

Group I: Nicardipine groupExperimental Treatment1 Intervention

Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.

Group II: Labetalol groupExperimental Treatment1 Intervention

Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.

Group III: Dexmedetomidine groupExperimental Treatment1 Intervention

Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.