Hypotensive Anesthesia for Orthognathic Surgery

NCT06093893 | Completed Phase 4 FDA Drug

• 1 other identifier: H-43663
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
2. 2.Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
3. 3.Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
4. 4.Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
5. 5.Dexmedetomidine, Nicardipine, and Labetalol's effect on adverse events.

Conditions

Orthognathic Surgery; Hypotensive Anesthesia

Keywords

Dexmedetomidine; Nicardipine; Labetalol; Surgeon visibility; Blood loss; Hemodynamic parameters; Operation time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Estimated blood loss

  immediately after surgery

• Mean systolic blood pressure during surgery

  throughout surgery every 5 minutes

• Mean arterial pressure

  throughout surgery every 5 minutes

• Mean heart rate

  throughout surgery every 5 minutes

• Operation time

  immediately after surgery

Study Arms (3)

Dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine

Nicardipine group

EXPERIMENTAL

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

Drug: Nicardipine

Labetalol group

EXPERIMENTAL

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

Drug: Labetalol

Interventions

Labetalol DRUG

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

Also known as: Labetalol hydrochloride injection

Labetalol group

Dexmedetomidine DRUG

1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.

Also known as: Precedex

Dexmedetomidine group

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

Also known as: Cardene

Nicardipine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Dexmedetomidine; Nicardipine; Labetalol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Officials

• Pushkar Mehra, DMD

  Oral and Maxillofacial Surgery Department, Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: March 4, 2025
• Primary Completion: January 7, 2026
• Study Completion: February 6, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)