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
Overview
- Phase
- Phase 4
- Intervention
- Dexmedetomidine
- Conditions
- Hypotensive Anesthesia
- Sponsor
- Boston Medical Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Surgical field visibility
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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:
- Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
- Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
- Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
- Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
- 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Dexmedetomidine group
Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
Intervention: Dexmedetomidine
Nicardipine group
Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
Intervention: Nicardipine
Labetalol group
Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.
Intervention: Labetalol
Outcomes
Primary Outcomes
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
- Mean arterial pressure(throughout surgery every 5 minutes)
- Mean heart rate(throughout surgery every 5 minutes)
- Mean systolic blood pressure during surgery(throughout surgery every 5 minutes)
- Operation time(immediately after surgery)
- Estimated blood loss(immediately after surgery)