Hypotensive Anesthesia for Jaw Surgery

Overseen By Madison Courtney, DDS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Boston Medical Center

Must not be taking: Beta blockers, Calcium channel blockers, Alpha 2 agonists

Disqualifiers: Allergy to medications, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications if you are on them at home, specifically beta blockers, calcium channel blockers, and alpha 2 agonists.

What data supports the effectiveness of the treatment Hypotensive Anesthesia for Jaw Surgery?

Research shows that hypotensive anesthesia can effectively reduce blood loss and improve the surgical field during jaw surgery. It has been found to decrease the need for blood transfusions and shorten surgery time, making it a beneficial treatment option when carefully monitored. ^{1 2 3 4 5}

Is hypotensive anesthesia safe for humans?

Hypotensive anesthesia, which lowers blood pressure during surgery, is generally safe for humans when used with careful patient selection and monitoring. Studies show it can reduce blood loss without significant changes in brain, heart, kidney, or liver functions, although it carries some risk of reduced blood flow to important organs. ^{1 2 5 6 7}

How does hypotensive anesthesia differ from other treatments for jaw surgery?

Hypotensive anesthesia is unique because it intentionally lowers blood pressure during surgery to reduce blood loss and improve the surgical field, unlike standard anesthesia which maintains normal blood pressure. This technique uses specific drugs like sevoflurane, halothane, and morphine, often in combination, to achieve the desired effect, but it carries risks such as reduced blood flow to vital organs. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

Pushkar Mehra, DMD

Principal Investigator

Oral and Maxillofacial Surgery Department, Boston Medical Center

Eligibility Criteria

This trial is for healthy adults needing jaw surgery at Boston Medical Center, with no home use of beta blockers, calcium channel blockers, or alpha 2 agonists. Participants must not be allergic to the study drugs, should speak English and cannot be pregnant.

Inclusion Criteria

I am generally healthy with minimal or mild systemic disease.

I am an adult scheduled for jaw surgery at Boston Medical Center with Dr. Mehra.

Exclusion Criteria

I am taking calcium channel blocker medication at home.

I am taking alpha 2 agonists at home.

I am currently taking a beta blocker medication at home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative visit to prepare participants for surgery

1 visit

Surgical Procedure

Participants undergo orthognathic surgery with hypotensive anesthesia using either Dexmedetomidine, Nicardipine, or Labetalol

1 day

1 visit (in-person)

Post-operative

1-week post-operation visit to assess recovery and collect outcome measures

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Hypotensive Anesthesia

Trial Overview The trial compares three blood pressure-lowering medications—Dexmedetomidine, Nicardipine, and Labetalol—used during anesthesia in jaw surgery. It's a double-blinded RCT where patients are randomly assigned to one of the three drug groups.

Participant Groups

Group I: Nicardipine group Experimental Treatment 1 Intervention

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

Group II: Labetalol group Experimental Treatment 1 Intervention

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

Group III: Dexmedetomidine group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Hypotensive anesthesia versus normotensive anesthesia during major maxillofacial surgery: a review of the literature. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Hypotensive anesthesia: Comparing the effects of different drug combinations on mean arterial pressure, estimated blood loss, and surgery time in orthognathic surgery. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Induced hypotension for orthognathic surgery. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Induced hypotensive anesthesia for adolescent orthognathic surgery patients. [2019]

5. Denmark pubmed.ncbi.nlm.nih.gov

Risks and benefits of deliberate hypotension in anaesthesia: a systematic review. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Deliberate hypotension for elective major maxillofacial surgery: a balance halothane and morphine technique. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Induced hypotension may influence blood loss in orthognathic surgery, but it is not crucial. [2019]