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NCT06093893 · ClinicalTrials.gov registry record · Phase 4
Hypotensive Anesthesia for Orthognathic Surgery
A Phase 4 study of Hypotensive Anesthesia and Orthognathic Surgery, sponsored by Boston Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06093893: Active Phase 4 study of Hypotensive Anesthesia and Orthognathic Surgery, sponsored by Boston Medical Center.
NCT06093893 is a Phase 4 study of Hypotensive Anesthesia and Orthognathic Surgery that is active but no longer recruiting, run by Boston Medical Center. The registered enrollment target is 90 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06093893, a Phase 4 study of Hypotensive Anesthesia and Orthognathic Surgery, is active but no longer recruiting, sponsored by Boston Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Labetalol
- DRUG Dexmedetomidine
- DRUG Nicardipine
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-03-04 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
What the registry record for NCT06093893 still lists
NCT06093893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Hypotensive Anesthesia appearing as the primary indexed condition, and to 3 interventions - of which Labetalol is the first listed.
NCT06093893 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06093893 about?
NCT06093893 is a clinical study titled "Hypotensive Anesthesia for 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 outco...
What is the current status of trial NCT06093893?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2025-03-04. Estimated completion is 2026-03.
What conditions does trial NCT06093893 study?
This clinical trial studies the following conditions: Hypotensive Anesthesia, Orthognathic Surgery.
What interventions are being tested in trial NCT06093893?
The interventions under investigation include: Labetalol (DRUG), Dexmedetomidine (DRUG), Nicardipine (DRUG).
Who is sponsoring clinical trial NCT06093893?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06093893 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06093893's enrollment target sits among peer trials
90 886th of 2000 higher than 1,089 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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