Clinical trial NCT06093893: Hypotensive Anesthesia for Orthognathic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypotensive Anesthesia
Orthognathic Surgery
Keywords: Dexmedetomidine
Nicardipine
Labetalol
Surgeon visibility
Blood loss
Hemodynamic parameters
Operation time
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Surgical field visibility
timeFrame: immediately after surgery
Secondary outcomes:
measure: Estimated blood loss
timeFrame: immediately after surgery
measure: Mean systolic blood pressure during surgery
timeFrame: throughout surgery every 5 minutes
measure: Mean arterial pressure
timeFrame: throughout surgery every 5 minutes
measure: Mean heart rate
timeFrame: throughout surgery every 5 minutes
measure: Operation time
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Oral and Maxillofacial Surgery Department, Boston Medical Center
name: Pushkar Mehra, DMD
role: PRINCIPAL_INVESTIGATOR
References: