Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07213544

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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

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