Remimazolam vs Propofol in Laser Burn Cases

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 4

Conditions: Hypertrophic Scarring; Procedural Sedation; Burn Scar

Treatments: Drug: Remimazolam besylate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07213544

Pro00146765

Details and patient eligibility

About

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).

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Remimazolam followed by Propofol

Active Comparator group

Description:

Patients will be randomized to receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive propofol 0.8 mg/kg IV bolus for sedation.

Treatment:

Drug: Propofol

Drug: Remimazolam besylate

Propofol followed by Remimazolam

Active Comparator group

Description:

Patients will be randomized to receive Propofol 0.8 mg/kg IV bolus for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation.

Treatment:

Drug: Propofol

Drug: Remimazolam besylate