Hypotensive Anesthesia for Orthognathic Surgery

Boston Medical Center (BMC)

Status and phase: Active, not recruiting; Phase 4

Conditions: Hypotensive Anesthesia; Orthognathic Surgery

Treatments: Drug: Nicardipine; Drug: Labetalol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06093893

H-43663

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Dexmedetomidine group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Nicardipine group

Experimental group

Description:

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

Treatment:

Drug: Nicardipine

Labetalol group

Experimental group

Description:

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

Treatment:

Drug: Labetalol