← Back to Search

Other

Hypotensive Anesthesia for Jaw Surgery

Phase 4
Waitlist Available
Led By Pushkar Mehra, DMD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy, American Society of Anesthesiologists (ASA) physical status classification system I or II
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
Must not have
Does not speak English
Patients on home calcium channel blocker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare 3 medications used to lower blood pressure during jaw surgery. 90 participants will be randomized into 3 groups, and the effects of the medications on several outcomes will be compared. Participants will be monitored for 1-3 months.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include changes in heart rate or blood pressure levels, dizziness or lightheadedness due to low blood pressure, potential allergic reactions to the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am generally healthy with minimal or mild systemic disease.
Select...
I am an adult scheduled for jaw surgery at Boston Medical Center with Dr. Mehra.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not speak English.
Select...
I am taking calcium channel blocker medication at home.
Select...
I am taking alpha 2 agonists at home.
Select...
I am currently taking a beta blocker medication at home.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical field visibility
Secondary study objectives
Estimated blood loss
Mean arterial pressure
Mean heart rate
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Nicardipine groupExperimental Treatment1 Intervention
Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
Group II: Labetalol groupExperimental Treatment1 Intervention
Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.
Group III: Dexmedetomidine groupExperimental Treatment1 Intervention
Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~2050
Nicardipine
2022
Completed Phase 4
~1940
Labetalol
2020
Completed Phase 4
~2490

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
402 Previous Clinical Trials
883,805 Total Patients Enrolled
Pushkar Mehra, DMDPrincipal InvestigatorOral and Maxillofacial Surgery Department, Boston Medical Center
~60 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top