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NCT07213544PHASE4Recruiting

Remimazolam vs Propofol in Laser Burn Cases

Medical University of South Carolina

Start Date

11/12/2025

Completion Date

1/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Remimazolam besylate

DRUG

Propofol

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Conditions

Burn ScarHypertrophic ScarringProcedural Sedation

Locations

Medical University of South Carolina

Charleston, South Carolina 29425

United States