Remimazolam-Propofol Combination Sedation for Gastrointestinal Endoscopy: A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Endoscopy; Procedural Sedation

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Romania
  • Timiș County
    • Timișoara, Timiș County, Romania, 300096
      • "Pius Brînzeu" Emergency County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural completion	Successful completion of the endoscopic procedure while maintaining adequate sedation (MOAA/S score ≤4) throughout	During procedure

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
• Investigators: Principal Investigator: Ovidiu Bedreag, MD, PhD, Victor Babes University of Medicine and Pharmacy Timisoara

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Propofol; Hemodynamic stability; Gastrointestinal endoscopy; Procedural sedation; Remimazolam; Recovery time; MOAA/S; Propofol-sparing
• Other Study ID Numbers: UMFT-REMI-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No