Efficacy, Safety and Patient Satisfaction of Patient-Controlled Remimazolam Sedation.
EU CTIS ID: 2026-525809-13-00
What this study is testing
To determine whether patient-controlled sedation with remimazolam for colonoscopy is safer and associated with greater patient satisfaction than physician-controlled sedation with remimazolam or midazolam.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age above or equal to 18 years old. ASA 1-3. Be able to understand and operate the PCS device (adequate understanding, manual dexterity, fluent in Danish.) Undergo diagnostic colonoscopy procedure with the intent of reaching the caecum and including cold snare polypectomies
You likely can't join if
- Scheduled for general anaesthesia or NAAP/NAPS. Allergy to midazolam, remimazolan, opioids or ingredients listed in the SmPC of the products. Any contraindication to midazolam, remimazolam or alfentanil. Undergoing therapeutic colonoscopy other than cold snare polypectomies. Pregnancy or breastfeeding. Daily use of benzodiazepines, opioids or opioid like medicine. Sleep apnoea. An alcohol intake of more than 10 standard drinks per week according to the guidelines of Sundhedstyrelsen.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.