Hypotensive Anesthesia for Orthognathic Surgery

Phase 4

Recruiting

• Conditions: Hypotensive Anesthesia; Orthognathic Surgery
• Interventions: Drug: Dexmedetomidine; Drug: Nicardipine; Drug: Labetalol

• Registration Number: NCT06093893
• Lead Sponsor: Boston Medical Center

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-23
• Status Verified: 2025-03
• Study Start: 2025-03-04
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
Nicardipine group	Nicardipine	Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
Labetalol group	Labetalol	Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.

Primary Outcome Measures

Name	Time	Method
Surgical field visibility	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 Outcome Measures

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

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States