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

NCT07604480 | Completed

• 1 other identifier: UMFT-REMI-2024
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation; Gastrointestinal Endoscopy

Keywords

Remimazolam; Propofol; Procedural sedation; Gastrointestinal endoscopy; Hemodynamic stability; Recovery time; MOAA/S; Propofol-sparing

Outcome Measures

Primary Outcomes (1)

• Procedural completion

  Successful completion of the endoscopic procedure while maintaining adequate sedation (MOAA/S score ≤4) throughout

  During procedure

Secondary Outcomes (6)

• Time to sedation onset

  During procedure

• Discharge readiness

  5 and 10 minutes post-procedure

• Incidence of hypotension

  During procedure

• Total propofol dose administered

  During procedure

• Total remimazolam dose administered

  During procedure

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥18 years Elective upper or lower gastrointestinal endoscopy (gastroscopy or colonoscopy) ASA physical status I-IV Written informed consent obtained prior to enrolment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy "Victor Babes" Timisoara: lead

Study Sites (1)

"Pius Brînzeu" Emergency County Hospital

Timișoara, Timiș County, 300096, Romania

Location

Study Officials

• Ovidiu Bedreag, MD, PhD

  Victor Babes University of Medicine and Pharmacy Timisoara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD candidate

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: November 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)