Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 18 years
Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy
Disqualifiers
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
Trial design
Treatments tested in this trial
- Remimazolam besylate
- Propofol
Treatment groups
136 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov