Remimazolam in Endoscopy: A Game-Changer for Safe and Effective Sedation in Real-World Practice

Aims This study aimed to evaluate the efficacy and safety of remimazolam as a sedative agent for procedural sedation-analgesia (PSA) in upper and lower gastrointestinal (GI) endoscopy

Methods A prospective, multicenter, real-world study was conducted between November 2024 and January 2025. Ninety-seven patients undergoing elective upper or lower GI endoscopy under PSA without anesthetist were enrolled. Inclusion criteria included adults with an ASA physical status of I, II, or III and a body mass index (BMI) between 18 and 50 kg/m². Exclusion criteria included: allergy to anesthetic drugs or a history of adverse reactions to anesthesia; glucose-6-phosphate dehydrogenase deficiency; severe respiratory disease; pregnant woman. All patients undergoing emergency or urgent GI endoscopy were excluded.

The primary outcomes were the sedative efficacy and safety of remimazolam during endoscopy. Efficacy was defined as successful sedation, measured by the ability to complete the endoscopic procedure without interruption due to inadequate sedation. Adverse events (AEs) were recorded, including severity (major or minor) and type (e.g., hypotension, hypoxia, bradycardia, nausea, vomiting, and injection site pain).Sedation was administered using a standardized protocol with remimazolam (5–7 mg induction dose with 2.5 mg supplemental doses, maximum 33 mg), with or without meperidine.

Results Of the 97 patients, 93 (95.9%) successfully completed the procedure with remimazolam sedation. The mean patient age was 59.16 years. Procedural success rates were 95% for colonoscopy and 90% for esophagogastroduodenoscopy. Sedation failures (n=4) were attributed to inadequate sedation, unrelated to ASA status. Minor AEs included hypotension (1 case, resolved with hydration), nausea (2 cases), vomiting (1 case), and hiccups (1 case); two of these patients received meperidine; no severe sedation-related AEs occurred. The mean supplemental dose of remimazolam was 5.5 mg. Patients receiving remimazolam with meperidine required lower meperidine doses (< 50 mcg). Recovery time was rapid, with patients fully alert within 5–10 minutes post-procedure. Post-procedural amnesia and absence of pain or discomfort were reported by most patients. Notably, remimazolam demonstrated safety and efficacy even in patients with a BMI>40 kg/m², with no requirement for flumazenil or rescue sedatives.

Conclusions Remimazolam proved to be an effective and safe sedative for GI endoscopy, offering high procedural success rates, rapid recovery, and minimal AEs. Its favorable safety profile, even in high-risk patients, supports its potential as a preferred sedative for PSA without anesthetist in routine GI endoscopy. This study is prospective real-world and had several limitations. First the number of patients was too small to accurately assess rare adverse events. Further randomized controlled trials with larger populations are recommended to confirm these results.

Publication History

Article published online:
27 March 2025