Age 65 and Older, ASA Class III/IV Patients, COPD III/IV, Multiple Organ Failure
Conditions
Brief summary
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.
Interventions
DRUGAdministering remimazolam
Administering Remimazolam for procedural sedation
DRUGAdministering propofol
Administering Propofol for procedural sedation
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 65 years or older * ASA Physical Status classification III or IV * Patients scheduled to undergo endoscopic procedures requiring procedural sedation * Ability to provide written informed consent
Exclusion criteria
* Age below 65 years * Pediatric population * Refusal or inability to provide informed consent * Severe allergy to study drugs * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate (beats per minute) | Periprocedural | The lowest heart rate will be recorded |
| Mean arterial pressure (mmHg) | Periprocedural | The lowest mean arterial pressure will be recorded |
| Incidence of hypotension requiring vasoactive support (Yes/No) | Periprocedural | The presence of hypotension requiring vasoactive drug administration will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Postprocedural | Patient satisfaction will be recorded as a single score per participant. |
| Endoscopist satisfaction (5-point Likert scale) | Periprocedural | Endoscopist satisfaction will be evaluated and recorded as a single 5-point Likert score per participant. |
| Quality of recovery (ordinal scale) | Periprocedural | Quality of recovery will be assessed using an ordinal clinical scale and reported as a single score per participant. |
| Incidence of postoperative nausea and vomiting (Yes/No) | Periprocedural | The presence of nausea and/or vomiting will be recorded. |
| Total dose of sedative administered (mg) | Periprocedural | Total intravenous dose of the sedative agent administered during the procedure. |
| Need for airway intervention due to apnea (Yes/No) | Periprocedural | The need for airway support due to apnea will be recorded. |
| Incidence of apnea (Yes/No) | Periprocedural | The occurrence of apnea during procedural sedation will be recorded. |
| Peripheral oxygen saturation (SpO₂,%) | Periprocedural | Peripheral capillary oxygen saturation will be measured using pulse oximetry and summarized as the mean periprocedural value. |
| Respiratory rate (breaths per minute) | Periprocedural | Respiratory rate will be monitored during the periprocedural period. |
| Duration of apnea (seconds) | Periprocedural | Duration of apnea episodes will be measured in seconds. |
| Need for change in sedation regimen (Yes/No) | Periprocedural | The need to change the planned sedation regimen will be recorded. |
| Incidence of postprocedural delirium (Yes/No) | Periprocedural | Postprocedural delirium or agitation will be recorded. |
| Incidence of adverse events (Yes/No) | Periprocedural | The occurrence of adverse events related to procedural sedation will be recorded. |
Countries
Romania
Outcome results
None listed