Study on Sedation for Colonoscopy: Comparing Remimazolam with Fentanyl and Midazolam with Fentanyl in Screening Patients

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive Remimazolam with Fentanyl, and the other group will receive Midazolam with Fentanyl. This is to compare the effectiveness of these medications for sedation during a colonoscopy.

2 medication administration

You will receive the assigned medications through an intravenous (IV) line. This means the medication will be given directly into your vein using a needle. The exact dosage and frequency will be determined by the medical team based on the study protocol.

3 colonoscopy procedure

During the colonoscopy, the medical team will monitor your sedation level and comfort. The procedure involves examining the inside of your colon using a flexible tube with a camera. The goal is to ensure you are comfortable and adequately sedated throughout the procedure.

4 recovery and discharge

After the procedure, you will be monitored until you meet the discharge criteria. This includes ensuring you are awake, alert, and comfortable. The total time from the start of medication to meeting the discharge criteria will be recorded as part of the study’s primary outcome.

5 post-procedure evaluation

You may be asked to rate any discomfort or pain using a simple scale. Your satisfaction with the procedure and the sedation will also be assessed. Additionally, the medical team will evaluate your cognitive function before discharge to ensure you are ready to leave safely.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hycgmp Hijqdsxv Herlev Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.03.2023

Trial locations

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.

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 ID:
2023-503470-21-00
Protocol code:
REMI2023
Trial Phase:
Therapeutic confirmatory (Phase III)

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