Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2025-03-04
2026-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexmedetomidine group
Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
Dexmedetomidine
1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.
Nicardipine group
Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
Nicardipine
1 mg will be administered intravenously and increase by 0.5-1 mg if the initial dose is ineffective, to a maximum of 15 mg / hour or
Labetalol group
Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.
Labetalol
20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;
Interventions
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Dexmedetomidine
1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.
Nicardipine
1 mg will be administered intravenously and increase by 0.5-1 mg if the initial dose is ineffective, to a maximum of 15 mg / hour or
Labetalol
20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy, American Society of Anesthesiologists (ASA) physical status classification system I or II
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pushkar Mehra, DMD
Role: PRINCIPAL_INVESTIGATOR
Oral and Maxillofacial Surgery Department, Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Madison Courtney, DDS
Role: primary
Other Identifiers
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H-43663
Identifier Type: -
Identifier Source: org_study_id