Browsing by Subject "Remimazolam"

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    Remimazolam for sedation in gastrointestinal endoscopy: A comprehensive review
    (Baishideng, 2024) Dahiya, Dushyant Singh; Kumar, Ganesh; Parsa, Syeda; Gangwani, Manesh Kumar; Ali, Hassam; Sohail, Amir Humza; Alsakarneh, Saqr; Hayat, Umar; Malik, Sheza; Shah, Yash R.; Mohan Pinnam, Bhanu Siva; Singh, Sahib; Mohamed, Islam; Rao, Adishwar; Chandan, Saurabh; Al-Haddad, Mohammad; Medicine, School of Medicine
    Worldwide, a majority of routine endoscopic procedures are performed under some form of sedation to maximize patient comfort. Propofol, benzodiazepines and opioids continue to be widely used. However, in recent years, Remimazolam is gaining immense popularity for procedural sedation in gastrointestinal (GI) endoscopy. It is an ultra-short-acting benzodiazepine sedative which was approved by the Food and Drug Administration in July 2020 for use in procedural sedation. Remimazolam has shown a favorable pharmacokinetic and pharmacodynamic profile in terms of its non-specific metabolism by tissue esterase, volume of distribution, total body clearance, and negligible drug-drug interactions. It also has satisfactory efficacy and has achieved high rates of successful sedation in GI endoscopy. Furthermore, studies have demonstrated that the efficacy of Remimazolam is non-inferior to Propofol, which is currently a gold standard for procedural sedation in most parts of the world. However, the use of Propofol is associated with hemodynamic instability and respiratory depression. In contrast, Remimazolam has lower incidence of these adverse effects intra-procedurally and hence, may provide a safer alternative to Propofol in procedural sedation. In this comprehensive narrative review, highlight the pharmacologic characteristics, efficacy, and safety of Remimazolam for procedural sedation. We also discuss the potential of Remimazolam as a suitable alternative and how it can shape the future of procedural sedation in gastroenterology.
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    Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial
    (Elsevier, 2021) Rex, Douglas K.; Bhandari, Raj; Lorch, Daniel G.; Meyers, Michael; Schippers, Frank; Bernstein, David; Medicine, School of Medicine
    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.