Burn ScarPhase 4NCT07213544
Remimazolam vs Propofol in Laser Burn Cases
A Phase 4 study testing Remimazolam besylate and Propofol in people with Burn Scar and Hypertrophic Scarring, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Scar, Hypertrophic Scarring, Procedural Sedation
- What is being tested?
- Remimazolam besylate and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Rishi Patel, M.D.
About this study
Official title: Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser
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).
Read the 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.
- Conditions
- Burn Scar, Hypertrophic Scarring, Procedural Sedation
- Being tested
- Remimazolam besylate, Propofol
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Remimazolam
PropofolDrug
Propofol
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam followed by Propofol | Active comparator | 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. Receives: Drug: Remimazolam besylate; Drug: Propofol |
| Propofol followed by Remimazolam | Active comparator | 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. Receives: Drug: Remimazolam besylate; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory depression
The incidence of respiratory depression will include need for advanced airway maneuvers, or hypopnea events. Advanced airway maneuvers during the laser therapy procedure may include jaw thrust, chin lift, insertion of oral or nasal airway, or bag mask ventilation. A hypopnea event is defined as a respiratory rate <8.
Measured: up to 24 hours after procedure ends
Secondary outcomes (5)
Time from initiation of sedation to peak sedation
Time from initiation of sedation to peak sedation will be measured in minutes and calculated from the start time of induction to peak sedation when patient reaches a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of less than 3. The MOAA/S scale ranges from 0 to 5, with higher scores indicating greater alertness and lower scores indicating deeper sedation:
5: Responds readily to name spoken in a normal tone. 4: Lethargic response to name spoken in a normal tone. 3: Responds only after name is called loudly or repeatedly. 2: Responds only after mild prodding or shaking.
1: Responds only after a painful trapezius squeeze. 0: Does not respond to a painful trapezius squeeze.
Measured: up to 24 hours after procedure ends
Time of cessation of sedation to full recovery
Time of cessation of sedation to full recovery will be evaluated in minutes by marking when the last dose of anesthetic medication is given (cessation of sedation), to when the patient has reached full recovery from anesthesia. Full recovery from anesthesia is defined as when the patient reaches a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≥ 4.
The MOAA/S scale ranges from 0 to 5, with higher scores indicating greater alertness and lower scores indicating deeper sedation:
5: Responds readily to name spoken in a normal tone. 4: Lethargic response to name spoken in a normal tone. 3: Responds only after name is called loudly or repeatedly. 2: Responds only after mild prodding or shaking.
1: Responds only after a painful trapezius squeeze. 0: Does not respond to a painful trapezius squeeze.
Measured: up to 24 hours after procedure ends
Cessation of sedation to full recovery
Cessation of sedation to full recovery will also be evaluated as length of PACU stay. This will be measured from the time the patient left the procedure room, to the time they are ready for discharge (marked as procedural care complete).
Measured: up to 24 hours after the procedure ends
Satisfaction with Anesthesia
Satisfaction with Anesthesia will be measured using the Iowa Satisfaction with Anesthesia Scale (ISAS) approximately 15 minutes to two hours after arrival to to the recovery unit. This measures their satisfaction with Monitored Anesthesia Care (MAC).
ISAS is an 11-item questionnaire designed to measure the satisfaction with monitored anesthesia care. The ISAS score is the mean of responses to all 11 questions. The score ranges from a minimum of -3 to a maximum of +3 when averaged together. The responses are: -3 = disagree very much, -2 = disagree moderately, -1 = disagree slightly, 1 = agree slightly, 2 = agree moderately, and 3 = agree very much. A score of +3 would imply a completely satisfied patient.
Measured: up to 24 hours after the procedure ends
Felling pain on injection of sedation medication
Subjects will be asked if they felt pain upon the injection of the sedation medications, and will answer "yes" or "no". This will be asked at least 15 minutes after arriving to the recovery area after the procedure. "No" indicates they did not feel pain upon injection which means a better outcome.
Measured: up to 24 hours after the procedure ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start12 Nov 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rishi Patel, Medical University of South Carolina
- Investigators
- Rishi Patel, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213544
- Sponsor's protocol ID
- Pro00146765
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser
- ClinicalTrials.gov ID
- NCT07213544
- Acronym / sponsor ID
- Pro00146765
- Conditions
- Burn Scar, Hypertrophic Scarring, Procedural Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam followed by Propofol | Active comparator | Drug: Remimazolam besylate, Drug: PropofolPatients 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. |
| Propofol followed by Remimazolam | Active comparator | Drug: Remimazolam besylate, Drug: PropofolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam besylateRemimazolam | Drug | Propofol followed by Remimazolam, Remimazolam followed by Propofol |
| PropofolPropofol | Drug | Propofol followed by Remimazolam, Remimazolam followed by Propofol |
Primary outcome
Incidence of respiratory depression
Time frame: up to 24 hours after procedure ends
The incidence of respiratory depression will include need for advanced airway maneuvers, or hypopnea events. Advanced airway maneuvers during the laser therapy procedure may include jaw thrust, chin lift, insertion of oral or nasal airway, or bag mask ventilation. A hypopnea event is defined as a respiratory rate <8.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rishi Patel, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam besylate and Propofol in people with Burn Scar and Hypertrophic Scarring, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Nitchie ((843) 792-1869, nitchie@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory depression (time frame: up to 24 hours after procedure ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.