Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06093893
The ClinicalTrials.gov registry entry for NCT06093893 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.