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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Medical Center
RECRUITING
Boston
Contact Information
Primary
Pushkar Mehra, DMD
pushkar.mehra@bmc.org
617-638-4350
Backup
Madison Courtney, DDS
Madison.Courtney@bmc.org
617-638-4350
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Boston Medical Center

This content was sourced from clinicaltrials.gov