Aims Remimazolam, a new ultra-short-acting benzodiazepine, has been licensed for intravenous
use in procedural sedation in Europe, the UK, and the USA, and for anesthesia in Asia.
The molecule has a rapid sedative effect and allows for quick recovery. The aim of
this single-center pilot study was to evaluate the effectiveness of Remimazolam in
comparison with standard sedation during level-II digestive endoscopic procedures.
Secondary outcomes included the rate of adverse events (safety), patient comfort after
awakening from sedation, and anesthesiologist satisfaction with procedural sedation.
Methods Data were collected from adult patients, ASA class≥II, undergoing level II endoscopic
procedures between January and May 2024. Sedation was performed according to the Remimazolam
Summary of Product Characteristics (SmPC) in combination with opioids (Fentanyl 50-100
mcg+Remimazolam 5 mg for patients under 65 years or 2.5-5 mg for patients≥65 years,
ASA III-IV, and those<50 kg). Additional doses of 1.25-2.5 mg were administered at
2-minute intervals until a Richmond Agitation-Sedation Scale (RASS) score of -3/-4
was reached. If adequate sedation was not achieved within 15 minutes, administration
of Propofol could be considered. The analysis was conducted by dividing patients into
two groups based on whether or not Propofol was used to ensure adequate sedation levels.
Complete awakening at the end of the procedure was defined using the Modified Observer’s
Alertness/Sedation score.
Results A total of 54 patients (30 males, median age 62) were enrolled in the study. Of them,
26 were ASA II, 27 ASA III, and 1 ASA IV. A total of 40 ERCP, 19 EUS, 11 EUS+ERCP
(consecutively), 4 colonoscopies, and 2 esophageal stenting procedures were performed,
with procedural duration ranging from 10 to 90 minutes. Age, BMI, and ASA scores were
homogeneously distributed. In 28 patients (51.8%), the procedure was completed with
Remimazolam+Fentanyl, while in 26 patients (48.2%), Propofol was also necessary. The
average dose of Remimazolam across all procedures was 13.74 mg (range: 2.5-22.5 mg).
The only factor related to the drug dosage was the duration of the procedure. EUS+ERCP
procedures more frequently required the addition of Propofol (81.8%). Among the adverse
events recorded, 10 cases of minor and transient desaturation were noted: 4 in the
group without Propofol and 6 in the group with Propofol (p=NS). Patient comfort upon
awakening was rated as 'excellent' by 44/54 patients (81.4%), with 25 in the group
without Propofol and 19 in the group with Propofol (p=NS). The anesthesiologist's
satisfaction was rated as “excellent” in 89% of cases when Propofol was not used,
but only in 19% of cases in the group where Propofol was necessary.
Conclusions Remimazolam has proven to be a safe drug with few adverse effects and was judged
as “comfortable” by the majority of patients after sedation. Further data are needed
to better understand this new 'soft drug.'
