Actively Recruiting
Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO2 Laser Therapy for Burn Scars
Led by Medical University of South Carolina · Updated on 2025-11-20
136
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates monitored anesthetic care using remimazolam versus propofol during fractional ablative CO2 laser therapy for burn scars. The study aims to compare the incidence of respiratory depression, defined by the need for advanced airway support or slow breathing rate, in patients undergoing laser treatment for burn scars and hypertrophic scarring. It is a randomized, single-blind, crossover trial where each participant receives both drugs in separate sessions. Participants are randomly assigned to receive either remimazolam or propofol for sedation during their first laser therapy session, followed by the alternate drug 4 to 6 weeks later in their second session. Remimazolam is given as a 0.075 mg/kg dose with a maximum of 5 mg, while propofol is administered as a 0.8 mg/kg intravenous bolus. This crossover approach allows direct comparison of the effects of these sedatives during outpatient laser procedures. During the study, participants will be monitored for respiratory depression, sedation onset and recovery times, changes in heart function, and overall satisfaction with anesthesia. Researchers will track outcomes up to 24 hours after each procedure, including pain felt during sedation injection. The study involves two outpatient laser sessions spaced several weeks apart, with assessments conducted throughout to ensure safety and collect detailed sedation data.
CONDITIONS
Brief Title
Remimazolam vs Propofol in Laser Burn Cases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled to undergo both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy
You will not qualify if you...
- History of previous fractional ablative laser therapy for burn scar
- Procedure expected to last longer than 30 minutes
- Allergy to dextran 40 or contraindication to remimazolam or propofol
- Pregnant or breastfeeding
- Unable or unwilling to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 weeks
Participants receive sedation with either remimazolam or propofol during their first fractional ablative CO2 laser therapy session, followed by the alternate drug during their second session 4 to 6 weeks later.
2 laser therapy sessions (in-person)
Duration - Up to 24 hours after each procedure
Participants are monitored for up to 24 hours after each sedation session to assess respiratory function, sedation onset and recovery times, hemodynamic changes, and satisfaction with anesthesia.
2 post-procedure monitoring periods
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
Haley Nitchie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here