Gastrointestinal Endoscopy, Procedural Sedation
Conditions
Keywords
Remimazolam, Propofol, Procedural sedation, Gastrointestinal endoscopy, Hemodynamic stability, Recovery time, MOAA/S, Propofol-sparing
Brief summary
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.
Interventions
None listed
Sponsors
University of Medicine and Pharmacy "Victor Babes" Timisoara
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural completion | During procedure | Successful completion of the endoscopic procedure while maintaining adequate sedation (MOAA/S score ≤4) throughout |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to sedation onset | During procedure | Time from first drug administration to achievement of adequate sedation (MOAA/S ≤4) |
| Discharge readiness | 5 and 10 minutes post-procedure | Modified Aldrete score at 5 and 10 minutes post-procedure; score ≥9 indicates readiness for discharge |
| Incidence of hypotension | During procedure | Systolic blood pressure \<90 mmHg or \>20% decrease from baseline during the procedure |
| Total propofol dose administered | During procedure | Cumulative intravenous propofol dose in milligrams |
| Total remimazolam dose administered | During procedure | Cumulative intravenous remimazolam dose in milligrams |
| Incidence of oxygen desaturation | During procedure | SpO₂ \<90% for ≥10 seconds during the procedure |
Countries
Romania
Contacts
PRINCIPAL_INVESTIGATOROvidiu Bedreag, MD, PhD
Victor Babes University of Medicine and Pharmacy Timisoara
Outcome results
None listed