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Sedation cocktail shows promise for routine scopes

NCT ID NCT07604480

Knowledge-focused Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether a mix of two sedatives, remimazolam and propofol, works well and safely for people having a gastrointestinal endoscopy (a scope procedure). Researchers watched 29 adults during their procedure to see if the sedation was effective and how quickly they recovered. The goal was to gather information on safety and effectiveness for future use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remimazolam and propofol combination
What this could lead to
If successful, this could point toward a safer and more effective sedation method for routine endoscopic procedures.
What could go wrong
This is a small, completed observational study with only 29 participants, so results may not apply to larger or more diverse groups. No major risks were highlighted, but sedation always carries some risk of breathing or heart problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

29 people

The number who actually took part.

Started

Nov 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal endoscopy Procedural sedation

Contacts and locations

Locations

  • "Pius Brînzeu" Emergency County Hospital

    Timișoara, Timiș County, 300096, Romania

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