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Compensation: Varies

Number of Visits: 2

136 Participants Needed

Remimazolam vs Propofol for Burn Scars

Overseen ByHaley Nitchie

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Disqualifiers: Previous laser therapy, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the performance of two sedatives, remimazolam and propofol, during laser therapy for burn scars. The primary goal is to determine which drug better minimizes breathing problems during the procedure. Participants will receive both drugs in separate sessions to compare their effects. The trial targets adults scheduled for two sessions of laser therapy to improve burn scars. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiming to understand its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Studies have shown that both remimazolam and propofol are generally well-tolerated for sedation. In studies with 1,248 participants, researchers compared remimazolam to midazolam and found it safe for use during procedures.

Research involving children highlighted propofol's safety and quick recovery times compared to other drugs, making it a preferred choice for its fast action and minimal side effects.

In studies focused on laser treatments for burn scars, both drugs were used with very few negative effects. This suggests a low risk of serious side effects for both drugs during these procedures.¹ ² ³ ⁴ ⁵

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Remimazolam and Propofol as sedation options for burn scar treatments due to their unique properties. Remimazolam is gaining attention because it acts quickly and wears off faster than many traditional sedatives, potentially leading to a shorter recovery time and fewer side effects. Propofol is already well-known for its rapid onset and controllable sedation depth, but pairing it with Remimazolam provides a chance to compare their effectiveness and safety directly. This trial could reveal if one offers significant advantages over the other, possibly improving patient comfort and outcomes during laser therapy sessions for burn scars.

What evidence suggests that this trial's treatments could be effective for burn scars?

This trial will compare remimazolam and propofol for sedation during laser treatments for burn scars. Studies have shown that both medications work well for sedation. Research suggests that remimazolam is effective and safe, with fewer breathing issues and stable blood pressure. Propofol helps patients recover quickly and reduces cell stress after a burn injury. Both medications have been successfully used in laser treatments for burn scars, providing strong evidence for their use in these procedures. Participants in this trial will receive either remimazolam followed by propofol or propofol followed by remimazolam in separate sessions.³ ⁴ ⁶ ⁷ ⁸

Who Is on the Research Team?

Rishi Patel, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Adults over 18 who are scheduled for two outpatient sessions of CO2 laser therapy to treat burn scars can join. They cannot be pregnant or breastfeeding, have had previous similar laser treatments, be allergic to study drugs or their components, or unable to consent.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for two sessions of CO2 laser therapy.

Exclusion Criteria

Pregnant and/or breastfeeding

My upcoming procedure is expected to take more than 30 minutes.

I have had laser therapy for a burn scar before.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Session 1

Participants receive either Remimazolam or Propofol during their first laser therapy session

1 day

1 visit (in-person)

Washout Period

A washout period of 4-6 weeks between the first and second treatment sessions

4-6 weeks

Treatment Session 2

Participants receive the alternate drug (Remimazolam or Propofol) during their second laser therapy session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after each treatment session

up to 24 hours after each procedure

What Are the Treatments Tested in This Trial?

Interventions

Propofol
Remimazolam

Trial Overview The trial is testing remimazolam against propofol during laser therapy for burn scars. It's a single-blind study where patients don't know which sedative they're getting and each patient will try both in different sessions.

How Is the Trial Designed?

2Treatment groups

Active Control

Group I: Remimazolam followed by PropofolActive Control2 Interventions

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.

Group II: Propofol followed by RemimazolamActive Control2 Interventions

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC3388335/

and Light-Based Therapies for the Treatment of Burn ScarsMost of the improvement in the burn scar was apparent after 1-2 sessions, but some individuals required up to 6 sessions to have a sustained and ...

2.e-century.use-century.us/files/ijcem/12/6/ijcem0074085.pdf

Propofol inhibits burn injury-induced oxidative stress ...Taken together, these results indicate that propofol protects the burn serum-injured cells, at least partly through upregulating SOD2 expression to reduce the ...

3.ctv.veeva.comctv.veeva.com/study/remimazolam-vs-propofol-in-laser-burn-cases

Remimazolam vs Propofol in Laser Burn CasesThis randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative ...

4.nature.comnature.com/articles/s41598-019-48724-x

Evaluation of the safety of using propofol for paediatric ...Our meta-analysis of 30 RCTs confirmed that propofol sedation had advantages in recovery time when compared with other drugs, without excessive concerns for ...

5.researchgate.netresearchgate.net/publication/229017274_Shine_on_Review_of_Laser-_and_Light-Based_Therapies_for_the_Treatment_of_Burn_Scars

and Light-Based Therapies for the Treatment of Burn ScarsWe will demonstrate that laser- and light-based therapies can be combined with each other safely to yield superior results, often at lower cost, ...

6.clinicaltrials.govclinicaltrials.gov/study/NCT07213544

Remimazolam vs Propofol in Laser Burn CasesOutcomes include respiratory depression, sedation onset and recovery times, hemodynamic changes, and patient satisfaction.

7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37856225/

Treatment of Hypertrophic Burn Scars With Laser TherapyThis study demonstrates minimal adverse events associated with FCL for hypertrophic burn scar treatment.

8.scholarlyworks.lvhn.orgscholarlyworks.lvhn.org/cgi/viewcontent.cgi?article=1554&context=research-scholars-posters

Outpatient Laser Treatment for Burn Scars is Safe and Effectiveimportant parameter. The purpose of the study is to determine if laser treatments are a safe and effective treatment option for burn scars.

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