Remimazolam vs Propofol for Burn Scars
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.12345Why 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.34678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Session 1
Participants receive either Remimazolam or Propofol during their first laser therapy session
Washout Period
A washout period of 4-6 weeks between the first and second treatment sessions
Treatment Session 2
Participants receive the alternate drug (Remimazolam or Propofol) during their second laser therapy session
Follow-up
Participants are monitored for safety and effectiveness after each treatment session
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?
2
Treatment groups
Active Control
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.
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
Citations
and Light-Based Therapies for the Treatment of Burn Scars
Most 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 ...
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 ...
Remimazolam vs Propofol in Laser Burn Cases
This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative ...
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.net
researchgate.net/publication/229017274_Shine_on_Review_of_Laser-_and_Light-Based_Therapies_for_the_Treatment_of_Burn_Scarsand Light-Based Therapies for the Treatment of Burn Scars
We will demonstrate that laser- and light-based therapies can be combined with each other safely to yield superior results, often at lower cost, ...
Remimazolam vs Propofol in Laser Burn Cases
Outcomes include respiratory depression, sedation onset and recovery times, hemodynamic changes, and patient satisfaction.
Treatment of Hypertrophic Burn Scars With Laser Therapy
This study demonstrates minimal adverse events associated with FCL for hypertrophic burn scar treatment.
8.
scholarlyworks.lvhn.org
scholarlyworks.lvhn.org/cgi/viewcontent.cgi?article=1554&context=research-scholars-postersOutpatient Laser Treatment for Burn Scars is Safe and Effective
important 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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