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Hypotensive Anesthesia for Orthognathic Surgery

Primary Purpose

Hypotensive Anesthesia, Orthognathic Surgery

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Nicardipine
Labetalol
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotensive Anesthesia focused on measuring Dexmedetomidine, Nicardipine, Labetalol, Surgeon visibility, Blood loss, Hemodynamic parameters, Operation time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dexmedetomidine group

Nicardipine group

Labetalol group

Arm Description

Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.

Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.

Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Estimated blood loss
This outcome will be calculated by the volume in suction minus the volume of irrigating fluid.
Mean systolic blood pressure during surgery
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Mean arterial pressure
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Mean heart rate
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Operation time
Operation time will be measured from time of first incision to procedure end, as recorded in electronic medical record.

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06093893
Brief Title
Hypotensive Anesthesia for Orthognathic Surgery
Official Title
A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Blood Loss, Surgeon Visibility, Hemodynamic Parameters, and Operation Time During Orthognathic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall objective of this double blinded, randomized controlled trial (RCT) is to compare specific outcomes three medications (Dexmedetomidine, Nicardipine, and Labetalol) which are routinely used to lower blood pressure used during general anesthesia for orthognathic (jaw) surgery. The investigators will evaluate healthy adult male and female patients who require jaw surgery at Boston Medical Center which will be performed by the principal investigator. The anticipated 90 participants will be randomized into three groups: Dexmedetomidine group, Nicardipine group, and Labetalol group. All medications will be given intravenously during their operation. Several outcomes (surgical field visibility, estimated blood loss, hemodynamic parameters -including systolic blood pressure, mean arterial pressure, and heart rate, operation time, and adverse events will be compared among the three groups. Each participant will be enrolled in the study for approximately 1-3 months. This time includes the pre-operative visit, the surgical procedure, and a 1-week post-operative visit. Each participant will be followed for 30 days post-operatively. These visits are part of the standard of care, and no additional visits will be required specifically for research purposes only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotensive Anesthesia, Orthognathic Surgery
Keywords
Dexmedetomidine, Nicardipine, Labetalol, Surgeon visibility, Blood loss, Hemodynamic parameters, Operation time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery.
Arm Title
Nicardipine group
Arm Type
Experimental
Arm Description
Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery.
Arm Title
Labetalol group
Arm Type
Experimental
Arm Description
Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Injection
Intervention Description
1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.
Intervention Type
Drug
Intervention Name(s)
Nicardipine
Other Intervention Name(s)
Nicardipine Hydrochloride Injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Labetalol
Other Intervention Name(s)
Labetalol hydrochloride injection
Intervention Description
20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;
Primary Outcome Measure Information:
Title
Surgical field visibility
Description
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.
Time Frame
immediately after surgery
Secondary Outcome Measure Information:
Title
Estimated blood loss
Description
This outcome will be calculated by the volume in suction minus the volume of irrigating fluid.
Time Frame
immediately after surgery
Title
Mean systolic blood pressure during surgery
Description
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Time Frame
throughout surgery every 5 minutes
Title
Mean arterial pressure
Description
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Time Frame
throughout surgery every 5 minutes
Title
Mean heart rate
Description
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Time Frame
throughout surgery every 5 minutes
Title
Operation time
Description
Operation time will be measured from time of first incision to procedure end, as recorded in electronic medical record.
Time Frame
immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pushkar Mehra, DMD
Phone
617-638-4350
Email
pushkar.mehra@bmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren R Anderson, DMD
Phone
617-638-4350
Email
lauren.anderson@bmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pushkar Mehra, DMD
Organizational Affiliation
Oral and Maxillofacial Surgery Department, Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren R Anderson, DMD
Phone
617-638-4350
Email
lauren.anderson@bmc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypotensive Anesthesia for Orthognathic Surgery

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