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Completed

NCT Number: NCT06093893

Hypotensive Anesthesia for Orthognathic Surgery

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.

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Key information

Conditions

Hypotensive Anesthesia Hemorrhage Orthognathic Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

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

Other names: Cardene

labetalol

Drug

20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;

Other names: Labetalol hydrochloride injection

Primary outcomes

  1. Surgical field visibility

    Time frame: immediately after surgery

    Surgical field visibility will be assessed using the Fromme's scale (0 = no bleeding, virtually bloodless field, 1 = bleeding, so mild it was not even a surgical nuisance, 2= moderate bleeding, a nuisance but without interference with accurate dissection, 3 = moderate bleeding that moderately compromised surgical dissection, 4 = bleeding, heavy but controllable, that significantly interfered with dissection, 5 = massive uncontrollable bleeding). This data will be obtained from the surgeon in the form of an electronic survey, and the mean value will be recorded.

Secondary outcomes

  1. Estimated blood loss

    Time frame: immediately after surgery

    This outcome will be calculated by the volume in suction minus the volume of irrigating fluid.

  2. Mean systolic blood pressure during surgery

    Time frame: throughout surgery every 5 minutes

    This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.

  3. Mean arterial pressure

    Time frame: throughout surgery every 5 minutes

    This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.

  4. Mean heart rate

    Time frame: throughout surgery every 5 minutes

    This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.

  5. Operation time

    Time frame: immediately after surgery

    Operation time will be measured from time of first incision to procedure end, as recorded in electronic medical record.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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