Hypotensive Anesthesia for Orthognathic Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthognathic Surgery; Hypotensive Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Nicardipine; Drug: Labetalol

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pushkar Mehra, DMD; Phone Number: 617-638-4350; Email: pushkar.mehra@bmc.org
• Study Contact Backup: Name: Lauren R Anderson, DMD; Phone Number: 617-638-4350; Email: lauren.anderson@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
      • Contact: Lauren R Anderson, DMD; Phone Number: 617-638-4350; Email: lauren.anderson@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical field visibility	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.	immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss	This outcome will be calculated by the volume in suction minus the volume of irrigating fluid.	immediately after surgery
Mean systolic blood pressure during surgery	This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.	throughout surgery every 5 minutes
Mean arterial pressure	This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.	throughout surgery every 5 minutes
Mean heart rate	This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.	throughout surgery every 5 minutes
Operation time	Operation time will be measured from time of first incision to procedure end, as recorded in electronic medical record.	immediately after surgery

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Pushkar Mehra, DMD, Oral and Maxillofacial Surgery Department, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Labetalol; Nicardipine; Blood loss; Hemodynamic parameters; Operation time; Surgeon visibility
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Dexmedetomidine; Labetalol; Nicardipine
• Other Study ID Numbers: H-43663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes