Remimazolam versus propofol for sedation during fractional CO₂ laser treatment of burn scars
Official title: Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser
Run by Medical University of South Carolina · NCT07213544 · Data updated 2026-11-12
This will test whether remimazolam or propofol leads to fewer breathing problems and faster recovery for adults having fractional CO₂ laser treatment for burn scars.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | November 12, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07213544 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older undergoing both outpatient fractional ablative CO₂ laser sessions for burn-scar treatment who can give informed consent and have no contraindications to remimazolam or propofol are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have allergies or contraindications to either drug, have had prior fractional ablative laser therapy to the scar, expect procedures longer than 30 minutes, or cannot give informed consent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, single-blind, crossover trial gives adult outpatients either remimazolam or propofol during their first fractional ablative CO₂ laser session and the alternate drug at a second session 4–6 weeks later. The primary outcome is respiratory depression, defined as need for advanced airway maneuvers (jaw thrust/chin lift, oral/nasal airway, or bag-mask ventilation) or hypopnea with respiratory rate < 8. Secondary outcomes include sedation onset and recovery times, hemodynamic changes, and patient satisfaction. Key exclusions are prior fractional ablative laser to the scar, procedures expected to last longer than 30 minutes, pregnancy or breastfeeding, and allergy or contraindication to either drug.
Why it matters
Potential benefit: If successful, this could reduce breathing complications and speed recovery during and after sedation for laser treatment of burn scars.
How similar studies have gone: Remimazolam has been studied in other procedural sedation settings and shown comparable sedation with quicker recovery than some agents, but direct head-to-head data versus propofol—especially for CO₂ laser treatment of burn scars—are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy Exclusion Criteria: * History of previous fractional ablative laser therapy for burn scar * Procedure expected to last longer than 30 minutes * Allergy such as dextran 40 or contraindication to either of the study drugs * Pregnant and/or breastfeeding * Subjects who are unable to or choose not to give informed consent
Where it's running
-
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Rishi Patel, MD — Medical University of South Carolina
- Study coordinator: Haley Nitchie
- Email: nitchie@musc.edu
- Phone: (843) 792-1869
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.