Remimazolam for Sedation During Endoscopy
(SERENE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two medicines, remimazolam and propofol, to determine which better keeps patients calm and comfortable during an endoscopy (a procedure where doctors use a camera to look inside the body). The researchers aim to discover if remimazolam could serve as a good alternative to the commonly used propofol. Individuals planning to undergo an endoscopy and who are generally healthy, as defined by the American Society of Anesthesiologists, might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially new treatment option.
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 team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that remimazolam is safe for sedation during endoscopic procedures. Research indicates it is generally well-tolerated and effective at keeping patients comfortably sedated. For example, one study found that remimazolam successfully sedated patients 93.5% of the time. Another study noted its safety even for older patients. Overall, remimazolam is considered a safe choice for sedation in these procedures.
In comparison, propofol is another commonly used sedative for similar procedures. Although this trial focuses on remimazolam, both treatments are generally regarded as safe for endoscopic sedation.12345Why are researchers excited about this trial's treatments?
Remimazolam is unique because it offers a potentially safer and more controlled sedation experience during endoscopy compared to the standard use of propofol. While propofol is effective, it can sometimes lead to deeper sedation than needed, requiring close monitoring. Remimazolam, however, has a more predictable effect and allows for quick recovery due to its rapid metabolism. Researchers are excited because remimazolam could provide patients with a smoother, more manageable sedation option, reducing the risk of complications and enhancing recovery times.
What evidence suggests that this trial's treatments could be effective for sedation during endoscopy?
This trial will compare Remimazolam with Propofol for sedation during endoscopic procedures. Research has shown that Remimazolam effectively calms patients, successfully sedating about 93.5% of them. It matches the effectiveness of Propofol, a commonly used sedative, with similar success rates. Remimazolam is also considered safe, making it suitable for patients at higher risk with sedation. It acts quickly and allows for a fast recovery after the procedure.12356
Who Is on the Research Team?
Oluwaseun Johnson-Akeju, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who are scheduled for an endoscopic procedure and have a physical status of I to III (mild to moderate health issues) according to the ASA classification.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either remimazolam or propofol for sedation during endoscopic procedures
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Propofol
- Remimazolam
Trial Overview
The study compares two sedation drugs, remimazolam and propofol, given randomly to patients during endoscopy. It aims to see how well each drug works and how practical it is to use them in real-world settings.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will receive remimazolam 0.20 mg/kg for procedural sedation. The maximum initial bolus will be 15 mg, with additional doses administered in 2.5 mg increments as needed to maintain adequate sedation. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This dosing strategy reflects the institution's standard-of-care approach to remimazolam-based sedation.
Participants randomized to this arm will receive propofol up to 1.5 mg/kg as the initial bolus, followed by intermittent boluses of 10-40 mg according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This regimen reflects the institution's standard-of-care approach to propofol-based sedation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
Efficacy and safety of remimazolam for sedation during ...
Results: Sixty-two patients were included in the analysis. The sedation success rate of 93.5% (84.3-98.2%) exceeded the threshold success rate ...
Efficacy and Safety of Remimazolam in Endoscopic ...
The results demonstrated that remimazolam had a strong sedative effect, and its sedative efficiency was significantly higher than that of placebo [OR = 0.01, 95 ...
Real‐World Evaluation of Remimazolam for Sedation ...
Remimazolam usage for gastrointestinal endoscopic sedation showed a favorable safety profile. Advanced age was associated with an increased risk ...
Efficacy and Safety of Remimazolam in Short Endoscopic ...
Conclusions: Remimazolam is a promising sedative for short endoscopic procedures due to its superior safety profile despite a slightly lower ...
Remimazolam, a novel drug, for safe and effective ...
Remimazolam is effective for inducing and maintaining procedural sedation, particularly during endoscopic procedures. It has emerged as a safe and efficacious ...
Comparative safety and efficacy of remimazolam versus ...
Remimazolam is a safe and effective alternative to propofol for sedation during ERCP, demonstrating comparable sedation efficacy, greater ...
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