Remimazolam versus propofol for sedation during fractional CO₂ laser treatment of burn scars
Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser
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 |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07213544 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.