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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery. |
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| Nicardipine group | Experimental | Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery. |
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| Labetalol group | Experimental | Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour. |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgical field visibility | Surgical field visibility will be assessed using the Fromme's scale (0 = no bleeding, virtually bloodless field, 1 = bleeding, so mild it was not even a surgical nuisance, 2= moderate bleeding, a nuisance but without interference with accurate dissection, 3 = moderate bleeding that moderately compromised surgical dissection, 4 = bleeding, heavy but controllable, that significantly interfered with dissection, 5 = massive uncontrollable bleeding). This data will be obtained from the surgeon in the form of an electronic survey, and the mean value will be recorded. | immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated blood loss | This outcome will be calculated by the volume in suction minus the volume of irrigating fluid. | immediately after surgery |
| Mean systolic blood pressure during surgery | This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pushkar Mehra, DMD | Oral and Maxillofacial Surgery Department, Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D009529 | Nicardipine |
| D007741 | Labetalol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Nicardipine | Drug | 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 |
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| Labetalol | Drug | 20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg; |
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| throughout surgery every 5 minutes |
| Mean arterial pressure | This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery. | throughout surgery every 5 minutes |
| Mean heart rate | This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery. | throughout surgery every 5 minutes |
| Operation time | Operation time will be measured from time of first incision to procedure end, as recorded in electronic medical record. | immediately after surgery |
| D004095 |
| Dihydropyridines |
| D011725 | Pyridines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |