Procedural SedationNCT07604480
Remimazolam-Propofol Combination Sedation for Gastrointestinal Endoscopy: A Prospective Observational Study
An observational study of Procedural Sedation and Gastrointestinal Endoscopy, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation, Gastrointestinal Endoscopy
- Type of treatment
- Injection or infusion
- How many people
- 29 participants
- Where
- 1 siteRomania
- Study dates
- 1 Nov 2024to 15 Mar 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years Elective upper or lower gastrointestinal endoscopy (gastroscopy or colonoscopy) ASA physical status I-IV Written informed consent obtained prior to enrolment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Romania1 site
"Pius Brînzeu" Emergency County Hospital
Timișoara, Timiș County, 300096
About this 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.
- Conditions
- Procedural Sedation, Gastrointestinal Endoscopy
- Keywords
- Remimazolam, Propofol, Procedural sedation, Gastrointestinal endoscopy, Hemodynamic stability, Recovery time, MOAA/S, Propofol-sparing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Procedural completion
Successful completion of the endoscopic procedure while maintaining adequate sedation (MOAA/S score ≤4) throughout
Measured: During procedure
Secondary outcomes (6)
Time to sedation onset
Time from first drug administration to achievement of adequate sedation (MOAA/S ≤4)
Measured: During procedure
Discharge readiness
Modified Aldrete score at 5 and 10 minutes post-procedure; score ≥9 indicates readiness for discharge
Measured: 5 and 10 minutes post-procedure
Incidence of hypotension
Systolic blood pressure <90 mmHg or >20% decrease from baseline during the procedure
Measured: During procedure
Total propofol dose administered
Cumulative intravenous propofol dose in milligrams
Measured: During procedure
Total remimazolam dose administered
Cumulative intravenous remimazolam dose in milligrams
Measured: During procedure
Incidence of oxygen desaturation
SpO₂ <90% for ≥10 seconds during the procedure
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Nov 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia-Elena Popovici, University of Medicine and Pharmacy "Victor Babes" Timisoara
- Investigators
- Ovidiu Bedreag, MD, PhD, Principal investigator, Victor Babes University of Medicine and Pharmacy Timisoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604480
- Sponsor's protocol ID
- UMFT-REMI-2024
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam-Propofol Combination Sedation for Gastrointestinal Endoscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07604480
- Acronym / sponsor ID
- UMFT-REMI-2024
- Conditions
- Procedural Sedation, Gastrointestinal Endoscopy
- Keywords
- Remimazolam, Propofol, Procedural sedation, Gastrointestinal endoscopy, Hemodynamic stability, Recovery time, MOAA/S, Propofol-sparing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" TimisoaraUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age ≥18 years Elective upper or lower gastrointestinal endoscopy (gastroscopy or colonoscopy) ASA physical status I-IV Written informed consent obtained prior to enrolment
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural completion
Time frame: During procedure
Successful completion of the endoscopic procedure while maintaining adequate sedation (MOAA/S score ≤4) throughout
6 secondary outcomes
Time to sedation onset
Time frame: During procedure
Discharge readiness
Time frame: 5 and 10 minutes post-procedure
Incidence of hypotension
Time frame: During procedure
Total propofol dose administered
Time frame: During procedure
Total remimazolam dose administered
Time frame: During procedure
Incidence of oxygen desaturation
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ovidiu Bedreag, MD, PhD principal investigator
Victor Babes University of Medicine and Pharmacy Timisoara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Sedation and Gastrointestinal Endoscopy, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural completion (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.