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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06093893
Other study ID # H-43663
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 2024
Est. completion date March 2025

Study information

Verified date May 2024
Source Boston Medical Center
Contact Pushkar Mehra, DMD
Phone 617-638-4350
Email pushkar.mehra@bmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 - Healthy, American Society of Anesthesiologists (ASA) physical status classification system I or II Exclusion Criteria: - Patients on a home beta blocker - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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;

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Estimated blood loss This outcome will be calculated by the volume in suction minus the volume of irrigating fluid. immediately after surgery
Secondary Mean systolic blood pressure during surgery This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery. throughout surgery every 5 minutes
Secondary Mean arterial pressure This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery. throughout surgery every 5 minutes
Secondary Mean heart rate This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery. throughout surgery every 5 minutes
Secondary Operation time Operation time will be measured from time of first incision to procedure end, as recorded in electronic medical record. immediately after surgery
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