Remimazolam vs Propofol in Laser Burn Cases
NCT07213544 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2025-11-20
Summary
This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust/chin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate \< 8).
Conditions
- Burn Scar
- Hypertrophic Scarring
- Procedural Sedation
Interventions
- DRUG
-
Remimazolam besylate
Remimazolam
- DRUG
-
Propofol
Propofol
Sponsors & Collaborators
-
Medical University of South Carolina
lead OTHER
Principal Investigators
-
Rishi Patel, MD · Medical University of South Carolina
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-12
- Primary Completion
- 2027-01-01
- Completion
- 2027-01-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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