Remimazolam vs Propofol in Laser Burn Cases

Conditions

• Burn Scar
• Hypertrophic Scarring
• Procedural Sedation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Remimazolam besylate — DRUG
  Remimazolam
• Propofol — DRUG
  Propofol

Study Details

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).

Key Dates

Start date

Nov 12, 2025

Status verified

Nov 2025

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

136 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Remimazolam followed by Propofol
  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.
• Active Comparator: Propofol followed by Remimazolam
  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.

Primary Outcome Measure

Incidence of respiratory depression [ Time Frame: up to 24 hours after procedure ends ]

Central Contacts

• Haley Nitchie
  (843) 792-1869
  [email protected]

Locations (1)

Find similar trials in Charleston, SC

Related Studies

• Novel Strategies for Reducing Burn Scar Itch
  PHASE3 · Recruiting · The University of Texas Medical Branch, Galveston · Galveston, Texas