Recruiting

Remimazolam vs. Propofol

Sponsor:

Medical University of South Carolina

Code:

NCT07213544

Conditions

Burn Scar

Hypertrophic Scarring

Procedural Sedation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remimazolam besylate

Propofol

Study Details

Brief 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).

Conditions

Burn Scar

Hypertrophic Scarring

Procedural Sedation

Study ID

NCT07213544

Start date

Nov 12, 2025

Status verified date

Nov, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Remimazolam besylate

Remimazolam

Propofol

Propofol

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Haley Nitchie

(843) 792-1869nitchie@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Rishi Patel, M.D.

More Information

Sponsor

Medical University of South Carolina

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-11-20.