NCT07213544

Remimazolam vs Propofol in Laser Burn Cases

Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients will be randomized to receive either remimazolam or propofol during their first laser session, and the alternate drug during their second session 4-6 weeks later. Outcomes include respiratory depression, sedation onset and recovery times, hemodynamic changes, and patient satisfaction.

Conditions

• Burn Scar
• Hypertrophic Scarring
• Procedural Sedation

Interventions

Type	Name	Description
DRUG	Remimazolam besylate	Remimazolam
DRUG	Propofol	Propofol

Timeline

• Start date: 2025-11-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-10-09
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study