NCT07213544 Remimazolam vs Propofol in Laser Burn Cases
| NCT ID | NCT07213544 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of South Carolina |
| Condition | Burn Scar |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 136 participants in total. It began in 2025-11-12 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Rishi Patel, MD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT07213544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burn Scar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07213544 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07213544 currently recruiting?
Yes, NCT07213544 is actively recruiting participants. Contact the research team at nitchie@musc.edu for enrollment information.
Where is the NCT07213544 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT07213544 clinical trial?
NCT07213544 is sponsored by Medical University of South Carolina. The principal investigator is Rishi Patel, MD at Medical University of South Carolina. The trial plans to enroll 136 participants.