A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy

Pambianco, Daniel J.; Borkett, Keith M.; Riff, Dennis; Winkle, Peter; Schwartz, Howard; Melson, Timothy; Wilhelm-Ogunbiyi, Karin

doi:10.1016/j.gie.2015.08.062

Cited by 121 publications

(151 citation statements)

References 23 publications

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“…These institutions will certainly need strong justification to switch to a more expensive agent like remimazolam. Taking into account that the U.S. phase IIb procedural sedation study allowed for up to six doses of remimazolam, and most patients randomized to any of the remimazolam groups received approximately three doses to complete the procedure, drug costs could be considerable. Aside from procedural sedation, it is unclear whether the relative cardiovascular benignity associated with remimazolam compared with propofol for induction and maintenance of general anesthesia is enough to offset the increased costs for use in general anesthesia cases.…”

Section: Discussionmentioning

confidence: 99%

“…The results of a U.S. phase II procedural sedation trial comparing single doses of remimazolam and midazolam followed by "top-up" dosing to maintain adequate sedation demonstrated a higher procedural success rate, faster onset of sedation, quicker time to full alertness, and faster time to discharge readiness with remimazolam. 5 No appreciable differences in safety or adverse effects were observed. It is noteworthy, however, that although varying doses of remimazolam were used to test for efficacy, a single dose of midazolam 2 mg was used for sedation induction across the board; thus some patients in the midazolam group may have been underdosed.…”

Section: Use In Procedural Sedationmentioning

confidence: 94%

“…The results of a U.S. phase II procedural sedation trial comparing single doses of remimazolam and midazolam followed by “top‐up” dosing to maintain adequate sedation demonstrated a higher procedural success rate, faster onset of sedation, quicker time to full alertness, and faster time to discharge readiness with remimazolam . No appreciable differences in safety or adverse effects were observed.…”

Section: Remimazolammentioning

confidence: 99%

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Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology

et al. 2016

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Midazolam, fentanyl, and propofol are commonly used for sedation in modern anesthesia practice. These agents possess characteristics that have afforded various anesthetics to be delivered and produce relatively safe and effective outcomes. However, each agent has certain drawbacks in clinical practice. Remimazolam, a novel benzodiazepine created out of so-called soft drug development, is an ultrashort-acting intravenous sedative-hypnotic currently being investigated in clinical trials. In this review, we evaluate the recent literature on the use of remimazolam in clinical practice as compared with current sedative agents, and we describe its potential roles for use in sedation. A literature search of the Medline database (2012-May 2016) was performed. Additional references were identified from a review of literature citations, manufacturer reports, and professional meeting abstracts. All premarket studies involving remimazolam as the primary study drug were evaluated. Literature describing the pharmacokinetics and pharmacodynamics of remimazolam, propofol, and midazolam was also included. Phase I and II studies in the United States have shown remimazolam to be a safe and effective option for procedural sedation. Unlike midazolam and propofol, remimazolam undergoes organ-independent metabolism to an inactive metabolite. Because remimazolam follows first-order pharmacokinetics, prolonged infusions or higher doses are unlikely to result in accumulation and extended effect, making it favorable for use as an intravenous anesthetic and for sedation in the intensive care unit. It is expected that phase III trials will further describe the niche that remimazolam may be able to occupy in clinical practice. Postmarket cost-benefit analyses will need to be performed.

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Section: Discussionmentioning

confidence: 99%

Section: Use In Procedural Sedationmentioning

confidence: 94%

Section: Remimazolammentioning

confidence: 99%

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Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology

et al. 2016

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“…The two novel hypnotic compounds have recently been progressed into advanced clinical development, remimazolam 51 and ABP-700 18 were both targeted in the first instance at sedation for gastrointestinal endoscopy. The business opportunity is to replace propofol sedation with a short-acting safe hypnotic suitable for use by non-anaesthetists whilst achieving an improved recovery profile in comparison to midazolam.…”

Section: Drivers For Developing New Hypnoticsmentioning

confidence: 99%

Thiopental to desflurane - an anaesthetic journey. Where are we going next?

Sneyd

2017

British Journal of Anaesthesia

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Development targets in anaesthetic pharmacology have evolved from minimizing harm caused by unwanted effects through an era in which rapid onset and offset of drug effect were prioritised. Today's anaesthetists have access to a library of effective drugs whose characteristics offer controllable hypnosis, analgesia and paralysis with manageable off-target effects. The availability of these agents at generic prices inhibits commercial interest and this is reflected in the limited number of current anaesthetic drug development projects. Recently, questions around neonatal neurotoxicity, delirium and postoperative cognitive dysfunction have stimulated research to characterise these phenomena and explain them in mechanistic terms. Emergent basic science from these enquiries together with exploration of possible effects of anaesthetic drug choice on patient outcomes from cancer surgery may yield new targets for drug discovery.

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“…Considering the increase in colonoscopies, there is an increasing demand for intravenous (IV) analgesics and sedatives. Increased demand and recent developments in the pharmacological area lead to the use of drugs with a broad therapeutic index, and the drugs are rapidly metabolized to inactive metabolites (3). The agents used for sedation should not cause respiratory depression, hemodynamic instability, and severe side effects (2).…”

Section: Introductionmentioning

confidence: 99%

Sedation for Colonoscopy: Comparison of Remifentanil and Alfentanil Combined with Propofol/Midazolam

Arıcan¹,

Çiçekci²,

Hacıbeyoğlu³

et al. 2019

Istanbul Med J

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Amaç: Kolonoskopi işlemi uygulanan hastalara güvenli sedasyon ve erken taburculuk amacıyla farklı ilaç kombinasyonları kullanılmaktadır. Remifentanil ve alfentanil kısa etkili narkotik analjezik ajanlardır. Kısa etkili bir anksiyolitik ajan olan midazolam narkotik analjeziklerle kombine edildiğinde güçlü bir sedadif etkinliğe sahiptir. Kolonoskopi işlemi altındaki hasta da sedasyon amacıyla literatürde karşılaştırılmamış 2 opiodin propofol/midazolam ile kombinasyonunun etkinliğini karşılaştırmayı amaçladık. Yöntemler: Çalışmaya tanı ve/veya tedavi amaçlı kolonoskopi uygulanan 18 yaş üzeri yüz seksen dokuz hasta alındı. Alfentanil grubunda (grup A) 1 mg midazolam + 5 µg kg-1 alfentanil + 1 mg kg-1 propofol ve remifentanil grubuna (grup R) 1 mg midazolam + 0.1 µg kg-1 dk-1 remifentanil + 1 mg kg-1 propofol uygulandı. Hemodinamik veriler, Modifiye Steward skalası (MSS), Görsel Analog skala (VAS), ek propofol dozları, toplam işlem süresi, uyanma süresi, iyileşme süresi ve yan etkiler işlem sırasında kaydedildi. İşlem sonrası tüm hastalar derlenme odasına transfer edildi ve Modifiye Aldrete skalası (MAS) değerleri kaydedildi. Bulgular: Total propofol ve ek propofol dozlarında gruplar arasında istatistiksel olarak anlamlı farklılık saptanmıştır (p<0.05), ve grup A da grup R ye göre propofol ek dozunun daha yüksek olduğu gözlenmiştir (p<0.05). Uyanma süresi gruplar arasında benzerdi. Derlenme süresinin grup A'da grup R'ye göre daha uzun olduğu tespit edildi (p<0.05). Gruplar arasında yan etkilerde anlamlı farklılık saptanmamıştır. Sonuç: Propofol/remifentanil ve propofol/alfentanil ile kombine edilen düşük doz midazolam etkili sedasyon ve analjezi sağlamasına rağmen, remifentanilin, farmakolojik özelliklerinden doğan avantajları nedeniyle kolonoskopi gibi günlük işlemler için ideal bir seçim olduğuna inanıyoruz.

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A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy

Cited by 121 publications

References 23 publications

Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology

Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology

Thiopental to desflurane - an anaesthetic journey. Where are we going next?

Sedation for Colonoscopy: Comparison of Remifentanil and Alfentanil Combined with Propofol/Midazolam

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