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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three medications—Dexmedetomidine, Nicardipine, and Labetalol—to lower blood pressure during jaw surgery. The goal is to determine which medication improves surgical visibility, reduces blood loss, and maintains surgery time, while also monitoring side effects. Healthy adults needing jaw surgery at Boston Medical Center, who are not on certain heart medications, might qualify. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments benefit a broader range of patients.

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 is the safety track record for these treatments?

Research shows that the three medications in this trial—Dexmedetomidine, Nicardipine, and Labetalol—are generally safe and well-tolerated for lowering blood pressure during jaw surgery.

Studies have found that Dexmedetomidine effectively reduces blood loss and improves patient recovery, with no major side effects reported. It also helps lessen pain, nausea, and vomiting after surgery.

Nicardipine lowers blood pressure during surgeries without causing harmful effects. Temporary changes in kidney function can occur, but these usually return to normal after use.

Labetalol safely manages blood pressure during surgery in healthy patients. While effective, it may cause a slow heart rate, known as bradycardia, in some cases.

Since this trial is in a late stage (Phase 4), these medications have been tested before and are considered safe for use in this context. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of hypotensive anesthesia in jaw surgery because it utilizes medications like Nicardipine, Labetalol, and Dexmedetomidine to lower blood pressure in a targeted way. Unlike standard anesthesia practices, which may not specifically aim to reduce blood pressure, these drugs help control bleeding during surgery, potentially improving surgical outcomes and recovery times. Each medication offers a unique approach: Nicardipine is a calcium channel blocker, Labetalol combines alpha and beta-blocking properties, and Dexmedetomidine provides sedative effects with minimal respiratory depression. These distinct mechanisms provide tailored options for anesthesiologists to optimize patient care during complex jaw surgeries.

What evidence suggests that this trial's treatments could be effective for jaw surgery?

This trial will compare the effects of different hypotensive anesthesia medications during jaw surgery. Participants will be randomized into one of three groups: the Dexmedetomidine group, the Nicardipine group, or the Labetalol group. Research has shown that dexmedetomidine can reduce blood loss by more than 50% and alleviate pain and nausea after surgery. Studies have found that nicardipine effectively lowers blood pressure, improving the surgical area and reducing blood loss. Labetalol also lowers blood pressure during surgery, helping to control blood loss and maintain a stable surgical environment. Each medication enhances surgical safety and may shorten procedures by improving visibility and reducing complications. ^{3 4 6 7 8}

Who Is on the Research Team?

Pushkar Mehra, DMD

Principal Investigator

Oral and Maxillofacial Surgery Department, Boston Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579933/

The effect of dexmedetomidine on perioperative events ... Dexmedetomidine appears to be a safe and effective option for reducing postoperative symptoms such as pain, nausea, vomiting, and cough in orthognathic surgery, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0020653925000152

Effect of Dexmedetomidine on Blood Loss and Patient ... Adding-on dexmedetomidine significantly reduced estimated blood loss by over 50% and improves patient outcomes.

3. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-021-00551-5

Effect of continuous infusion of dexmedetomidine on blood ... Dexmedetomidine has been used in controlled hypotension and may reduce blood loss in orthognathic surgery. We conducted a retrospective cohort ...

4. joms.org joms.org/article/S0278-2391(14)01240-3/abstract

Evaluation of the Advantageous Anesthetic Properties ... Dexmedetomidine, used as a hypotensive drug, has anesthetic benefits compared with nitroglycerin. Dexmedetomidine decreases the intraoperative fentanyl ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06093893?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(LABETALOL%20HYDROCHLORIDE))&rank=2

Hypotensive Anesthesia for Orthognathic Surgery The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142777/

Effect of Dexmedetomidine on Blood Loss and Patient ... In conclusion, adding-on dexmedetomidine in orthognathic surgery significantly reduced estimated blood loss by over 50% and improved patient outcomes, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0929664625000518

Dexmedetomidine infusion on blood loss in orthognathic ... Our findings demonstrate that dexmedetomidine effectively achieved controlled hypotension during orthognathic surgery, resulting in 217 ml ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06093893

Hypotensive Anesthesia for Orthognathic Surgery The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events. The ...