Hypotensive Anesthesia for Orthognathic Surgery

Conditions

• Hypotensive Anesthesia
• Orthognathic Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexmedetomidine — DRUG
  1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.
• Nicardipine — DRUG
  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
• Labetalol — DRUG
  20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;

Study Details

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.

Key Dates

Start date

Mar 4, 2025

Status verified

Mar 2026

Primary completion

Jan 7, 2026

Completion

Feb 6, 2026

Study Design

Enrollment

90 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dexmedetomidine group
  Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
• Experimental: Nicardipine group
  Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
• Experimental: Labetalol group
  Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.

Primary Outcome Measure

Surgical field visibility [ Time Frame: immediately after surgery ]

Locations (1)

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