Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or high-risk patients. Advantages include better hemodynamic stability, reduced respiratory depression, lower incidence of postoperative delirium, and rapid recovery without residual sedation. It is metabolized by liver esterases and is less affected by organ dysfunction. Clinical studies suggest that remimazolam may be a safer and more effective alternative in procedural and general anesthesia. The findings support the development of institutional protocols for its use, particularly in high-risk populations and endoscopic procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Administering Remimazolam for procedural sedation
Administering Propofol for procedural sedation
Regional Institute of Gastroenterology-Hepatology Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj, Romania
RECRUITINGHeart rate (beats per minute)
The lowest heart rate will be recorded
Time frame: Periprocedural
Mean arterial pressure (mmHg)
The lowest mean arterial pressure will be recorded
Time frame: Periprocedural
Incidence of hypotension requiring vasoactive support (Yes/No)
The presence of hypotension requiring vasoactive drug administration will be recorded.
Time frame: Periprocedural
Patient satisfaction
Patient satisfaction will be recorded as a single score per participant.
Time frame: Postprocedural
Endoscopist satisfaction (5-point Likert scale)
Endoscopist satisfaction will be evaluated and recorded as a single 5-point Likert score per participant.
Time frame: Periprocedural
Quality of recovery (ordinal scale)
Quality of recovery will be assessed using an ordinal clinical scale and reported as a single score per participant.
Time frame: Periprocedural
Incidence of postoperative nausea and vomiting (Yes/No)
The presence of nausea and/or vomiting will be recorded.
Time frame: Periprocedural
Total dose of sedative administered (mg)
Total intravenous dose of the sedative agent administered during the procedure.
Time frame: Periprocedural
Need for airway intervention due to apnea (Yes/No)
The need for airway support due to apnea will be recorded.
Time frame: Periprocedural
Incidence of apnea (Yes/No)
The occurrence of apnea during procedural sedation will be recorded.
Time frame: Periprocedural
Peripheral oxygen saturation (SpO₂,%)
Peripheral capillary oxygen saturation will be measured using pulse oximetry and summarized as the mean periprocedural value.
Time frame: Periprocedural
Respiratory rate (breaths per minute)
Respiratory rate will be monitored during the periprocedural period.
Time frame: Periprocedural
Duration of apnea (seconds)
Duration of apnea episodes will be measured in seconds.
Time frame: Periprocedural
Need for change in sedation regimen (Yes/No)
The need to change the planned sedation regimen will be recorded.
Time frame: Periprocedural
Incidence of postprocedural delirium (Yes/No)
Postprocedural delirium or agitation will be recorded.
Time frame: Periprocedural
Incidence of adverse events (Yes/No)
The occurrence of adverse events related to procedural sedation will be recorded.
Time frame: Periprocedural
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