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Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial
Douglas K Rex1, Raj Bhandari2, Daniel G Lorch3
1Indiana University School of Medicine, 550 North University Boulevard, Suite 4100, Indianapolis, IN 46202, United States.
Background:
Procedural sedation of ASA III/IV patients has increased risk. Remimazolam (an ultra-short-acting benzodiazepine) has proven safe and efficient for outpatient colonoscopy sedation.
Methods:
A double-blind, randomized, multi-center, parallel group trial was performed, comparing remimazolam to placebo with an additional open-label arm for midazolam in procedural sedation of 79 ASA III/IV patients undergoing colonoscopy. This was the third of 3 Phase III trials for remimazolam in the procedural sedation program. The primary end point was the safety of remimazolam.
Results:
Of 79 patients randomized at 3 US sites, 77 underwent sedation and colonoscopy (31 received remimazolam, 16 placebo and 30 midazolam). Incidence and frequency of treatment emergent adverse events (TEAEs) were comparable in all three treatment arms, and independent of ASA status. One TEAE leading to discontinuation and one serious TEAE were reported; both in the open label midazolam arm. The efficacy endpoint was achieved for remimazolam, placebo, and midazolam in 87.1%, 0%, and 13.3% of patients (p<0.00001 for remimazolam versus placebo and versus midazolam, respectively).
Conclusions:
Remimazolam is safe and efficient in procedural sedation of high risk ASA patients undergoing colonoscopy, showing a safety profile comparable to that in low risk ASA.
Insights
Remimazolam offers a safe and effective option for procedural sedation in high-risk patients undergoing colonoscopy. This ultra-short-acting benzodiazepine demonstrated comparable safety to midazolam, with excellent efficacy in ASA III/IV patients.
Area of Science:
- Anesthesiology
- Gastroenterology
- Pharmacology
Background:
- Procedural sedation for patients with American Society of Anesthesiologists (ASA) physical status III/IV classifications carries increased risks.
- Remimazolam, an ultra-short-acting benzodiazepine, has emerged as a potentially safe and efficient agent for procedural sedation, particularly in outpatient settings like colonoscopy.
Purpose of the Study:
- To evaluate the safety and efficacy of remimazolam for procedural sedation in high-risk (ASA III/IV) patients undergoing colonoscopy.
- To compare remimazolam with placebo and midazolam in this patient population.
Main Methods:
- A double-blind, randomized, multi-center, parallel-group trial was conducted.
- 79 ASA III/IV patients undergoing colonoscopy were randomized to receive remimazolam, placebo, or midazolam (open-label).
- The primary endpoint was the safety of remimazolam, with efficacy as a secondary endpoint.
Main Results:
- Treatment-emergent adverse events were comparable across remimazolam, placebo, and midazolam arms, irrespective of ASA status.
- Efficacy was achieved in 87.1% of patients receiving remimazolam, compared to 0% for placebo and 13.3% for midazolam (p<0.00001).
- No serious adverse events were reported in the remimazolam arm.
Conclusions:
- Remimazolam is a safe and effective agent for procedural sedation in high-risk ASA III/IV patients undergoing colonoscopy.
- Its safety profile in this population is comparable to that observed in lower-risk patients.
- Remimazolam presents a viable alternative for sedation in challenging patient groups.
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