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.
