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Completed

NCT Number: NCT07604480

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.

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Key information

Conditions

Procedural Sedation Gastrointestinal Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Pius Brînzeu" Emergency County Hospital

Timișoara, Timiș County, 300096, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Procedural completion

    Time frame: During procedure

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

Secondary outcomes

  1. Time to sedation onset

    Time frame: During procedure

    Time from first drug administration to achievement of adequate sedation (MOAA/S ≤4)

  2. Discharge readiness

    Time frame: 5 and 10 minutes post-procedure

    Modified Aldrete score at 5 and 10 minutes post-procedure; score ≥9 indicates readiness for discharge

  3. Incidence of hypotension

    Time frame: During procedure

    Systolic blood pressure <90 mmHg or >20% decrease from baseline during the procedure

  4. Total propofol dose administered

    Time frame: During procedure

    Cumulative intravenous propofol dose in milligrams

  5. Total remimazolam dose administered

    Time frame: During procedure

    Cumulative intravenous remimazolam dose in milligrams

  6. Incidence of oxygen desaturation

    Time frame: During procedure

    SpO₂ <90% for ≥10 seconds during the procedure

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy "Victor Babes" Timisoara

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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