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This prospective observational study evaluated the safety and efficacy of a remimazolam-propofol combination sedation protocol in adult patients undergoing elective gastrointestinal endoscopy at a tertiary care centre in Romania. The primary outcome was procedural completion. Secondary outcomes included time to sedation onset, recovery time, discharge readiness, total sedative doses administered, and incidence of adverse events including cardiovascular and respiratory complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam-Propofol group | Adult patients undergoing elective gastrointestinal endoscopy (gastroscopy or colonoscopy) receiving a standardised combination sedation protocol consisting of intravenous fentanyl premedication followed by remimazolam and propofol, titrated to a target MOAA/S score ≤4. |
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| Measure | Description | Time Frame |
|---|---|---|
| Procedural completion | Successful completion of the endoscopic procedure while maintaining adequate sedation (MOAA/S score ≤4) throughout | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sedation onset | Time from first drug administration to achievement of adequate sedation (MOAA/S ≤4) | During procedure |
| Discharge readiness | Modified Aldrete score at 5 and 10 minutes post-procedure; score ≥9 indicates readiness for discharge |
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Inclusion Criteria:
Age ≥18 years Elective upper or lower gastrointestinal endoscopy (gastroscopy or colonoscopy) ASA physical status I-IV Written informed consent obtained prior to enrolment
Exclusion Criteria:
Age <18 years ASA physical status V Emergency endoscopic procedures Known allergy or hypersensitivity to remimazolam, propofol, fentanyl, or any component of their formulations Severe hepatic impairment Pregnancy or breastfeeding History of difficult airway or anticipated airway management difficulties Refusal of informed consent Participation in another clinical trial at the time of enrolment
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Adult patients undergoing elective gastrointestinal endoscopy (gastroscopy or colonoscopy) at the Endoscopy Department of "Pius Brînzeu" Emergency County Hospital, Timișoara, Romania. The study population reflects a real-world tertiary care cohort with a high prevalence of cardiovascular comorbidities, predominantly ASA physical status III.
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| Name | Affiliation | Role |
|---|---|---|
| Ovidiu Bedreag, MD, PhD | Victor Babes University of Medicine and Pharmacy Timisoara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Pius Brînzeu" Emergency County Hospital | Timișoara | Timiș County | 300096 | Romania |
Individual participant data cannot be shared publicly due to patient privacy and confidentiality requirements in accordance with Romanian data protection legislation and the General Data Protection Regulation (GDPR). De-identified data may be available from the corresponding author on reasonable request.
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| 5 and 10 minutes post-procedure |
| Incidence of hypotension | Systolic blood pressure <90 mmHg or >20% decrease from baseline during the procedure | During procedure |
| Total propofol dose administered | Cumulative intravenous propofol dose in milligrams | During procedure |
| Total remimazolam dose administered | Cumulative intravenous remimazolam dose in milligrams | During procedure |
| Incidence of oxygen desaturation | SpO₂ <90% for ≥10 seconds during the procedure | During procedure |