Herlev Hospital
Verified
Herlev, Denmark
Not recruiting
Study on Sedation for Colonoscopy: Comparing Remimazolam with Fentanyl and Midazolam with Fentanyl in Screening Patients
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on evaluating the effectiveness of two different sedation methods used during a screening procedure called a colonoscopy, which is often performed to check for colon cancer. The study compares the use of Remimazolam combined with Fentanyl against Midazolam combined with Fentanyl. Remimazolam and Midazolam are medications that help relax patients and make them sleepy during medical procedures, while Fentanyl is a pain reliever. The goal is to see if using Remimazolam with Fentanyl can make the procedure and recovery time shorter compared to using Midazolam with Fentanyl.
Participants in the study will receive one of the two sedation combinations before their colonoscopy. The study will measure how long it takes from the start of the medication until the patient meets the criteria to be safely discharged. Other aspects being observed include whether patients need extra time in a recovery room, their comfort and pain levels, how quickly the procedure reaches a certain point in the colon, and whether additional doses of Fentanyl or other sedatives are needed. The satisfaction of both the patients and the doctors performing the procedure will also be assessed, along with the patients' cognitive function, which refers to their ability to think and remember, at the time of discharge.
The purpose of this study is to determine if Remimazolam with Fentanyl can improve the sedation process by making it quicker and more comfortable for patients undergoing a colonoscopy. This could potentially lead to better experiences for patients and more efficient procedures for healthcare providers.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
3 criteria
- Must be over 18 years old.
- Must be scheduled for a planned colonoscopy to check for colon cancer.
- Must be able to provide written consent after understanding the study details.
Who cannot join the trial?
3 criteria
- Patients who are not undergoing a screening colonoscopy cannot participate. A screening colonoscopy is a procedure to check the inside of the colon for any abnormalities or signs of disease.
- Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
- Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs
Remimazolam
is a medication used to help patients relax and feel sleepy during medical procedures. It works quickly and helps patients recover faster after the procedure is over. In this study, it is being tested to see if it can make the process of having a colonoscopy smoother and quicker compared to another medication.
Fentanyl
is a strong pain reliever that is often used during medical procedures to help manage pain. It is used in combination with other medications to ensure that patients are comfortable and do not feel pain during the procedure.
Midazolam
is another medication used to help patients relax and feel sleepy during medical procedures. It is commonly used for sedation, but in this study, it is being compared to Remimazolam to see which one helps patients recover faster after a colonoscopy.
What is already known about the treatment
Remimazolam
Remimazolam is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its use in sedation during procedures like colonoscopies. The main therapeutic indication for Remimazolam is to provide sedation, which helps patients relax and feel comfortable during medical procedures. At the molecular level, Remimazolam works by enhancing the effects of a neurotransmitter called GABA in the brain, which helps to calm the nervous system. It is classified as a benzodiazepine, a type of medication commonly used for sedation, anxiety relief, and muscle relaxation.
Fentanyl
Fentanyl is also administered intravenously and is used in combination with other medications for sedation during medical procedures. It is well-established in medical practice and literature as a powerful pain reliever and sedative. The main therapeutic indication for Fentanyl is to provide pain relief and sedation. At the molecular level, Fentanyl works by binding to opioid receptors in the brain, which blocks pain signals and produces a calming effect. It is classified as an opioid analgesic, a group of medications used to treat severe pain and provide sedation.
Investigated diseases
Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, benign clumps of cells called polyps that can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby. The cancer may spread to other parts of the body, a process known as metastasis. Symptoms often include changes in bowel habits, blood in the stool, and abdominal discomfort. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503470-21-00Protocol codeREMI2023Estimated enrolment200 patientsSponsorRegion Hovedstaden
sourced from the EU Clinical Trials Register and site verification
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