Remimazolam vs Propofol in Laser Burn Cases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam besylate, Propofol.
- Who it may be relevant to
- Registry conditions: Burn Scar, Hypertrophic Scarring, Procedural Sedation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser
Overview
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.
Interventions
- Drug Remimazolam besylate
Remimazolam - Drug Propofol
Propofol
Primary outcome measures
- Incidence of respiratory depression [Time frame: up to 24 hours after procedure ends]
Secondary outcome measures (5)
- Time from initiation of sedation to peak sedation [Time frame: up to 24 hours after procedure ends]
- Time of cessation of sedation to full recovery [Time frame: up to 24 hours after procedure ends]
- Cessation of sedation to full recovery [Time frame: up to 24 hours after the procedure ends]
- Satisfaction with Anesthesia [Time frame: up to 24 hours after the procedure ends]
- Felling pain on injection of sedation medication [Time frame: up to 24 hours after the procedure ends]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT07213544 · Pro00146765