Hypotensive AnesthesiaPhase 4NCT06093893
Hypotensive Anesthesia for Orthognathic Surgery
A Phase 4 study testing Dexmedetomidine, Nicardipine and Labetalol in people with Hypotensive Anesthesia and Orthognathic Surgery, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotensive Anesthesia, Orthognathic Surgery
- What is being tested?
- Dexmedetomidine, Nicardipine and Labetalol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 6 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Surgeon Visibility, Blood Loss, Hemodynamic Parameters, Operation Time, and Adverse Events During Orthognathic Surgery
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:
Read more
- Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
- Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
- Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
- Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
- 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.
- Conditions
- Hypotensive Anesthesia, Orthognathic Surgery
- Being tested
- Dexmedetomidine, Nicardipine, Labetalol
- Keywords
- Dexmedetomidine, Nicardipine, Labetalol, Surgeon visibility, Blood loss, Hemodynamic parameters, Operation time
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour.
NicardipineDrug
Also called Cardene
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
LabetalolDrug
Also called Labetalol hydrochloride injection
20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg;
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Participants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery. Receives: Drug: Dexmedetomidine |
| Nicardipine group | Experimental | Participants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery. Receives: Drug: Nicardipine |
| Labetalol group | Experimental | Participants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery. Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after surgery
Secondary outcomes (5)
Estimated blood loss
This outcome will be calculated by the volume in suction minus the volume of irrigating fluid.
Measured: 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.
Measured: throughout surgery every 5 minutes
Mean arterial pressure
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Measured: throughout surgery every 5 minutes
Mean heart rate
This outcome will be automatically recorded in the electronic medical record every 5 minutes during surgery.
Measured: 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.
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start4 Mar 2025
- Primary completion7 Jan 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotensive AnesthesiaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pushkar Mehra, DMD, Principal investigator, Oral and Maxillofacial Surgery Department, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093893
- Sponsor's protocol ID
- H-43663
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Surgeon Visibility, Blood Loss, Hemodynamic Parameters, Operation Time, and Adverse Events During Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06093893
- Acronym / sponsor ID
- H-43663
- Conditions
- Hypotensive Anesthesia, Orthognathic Surgery
- Keywords
- Dexmedetomidine, Nicardipine, Labetalol, Surgeon visibility, Blood loss, Hemodynamic parameters, Operation time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
- Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
- Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
- Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineParticipants randomized into this group will be given Dexmedetomidine to lower their blood pressure during jaw surgery. |
| Nicardipine group | Experimental | Drug: NicardipineParticipants randomized into this group will be given Nicardipine to lower their blood pressure during jaw surgery. |
| Labetalol group | Experimental | Drug: LabetalolParticipants randomized into this group will be given Labetalol to lower their blood pressure during jaw surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Precedex1 mcg/kg will be administered intravenously over 10 minutes; followed by maintenance infusion of 0.2 to 1 mcg/kg/hour. | Drug | Dexmedetomidine group |
| NicardipineAlso: Cardene1 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 | Drug | Nicardipine group |
| LabetalolAlso: Labetalol hydrochloride injection20 - 80 mg will be administered intravenously at 10-minute intervals to maximum of 300 mg; | Drug | Labetalol group |
Primary outcome
Surgical field visibility
Time frame: immediately after surgery
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.
5 secondary outcomes
Estimated blood loss
Time frame: immediately after surgery
Mean systolic blood pressure during surgery
Time frame: throughout surgery every 5 minutes
Mean arterial pressure
Time frame: throughout surgery every 5 minutes
Mean heart rate
Time frame: throughout surgery every 5 minutes
Operation time
Time frame: immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Effect of the Superficial Cervical Plexus Block in the Hypotensive Anesthesia of Ear Surgery.
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Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries
Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY
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AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pushkar Mehra, DMD principal investigator
Oral and Maxillofacial Surgery Department, Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Nicardipine and Labetalol in people with Hypotensive Anesthesia and Orthognathic Surgery, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical field visibility (time frame: immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.