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Comparing Remimazolam and Propofol for Deep Sedation in Patients Undergoing Endoscopic Ultrasound for Gastric and Pancreatic Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with gastric and pancreatic cancer who need a procedure called endoscopic ultrasound, which is a test that uses a thin tube with a camera and sound waves to look inside the digestive system and nearby organs. During this procedure, patients receive medications to help them relax and sleep, which is called deep sedation. The study will compare two different medications used for sedation: remimazolam and propofol. When remimazolam is used, the sedation will be managed by the doctor performing the endoscopy procedure, while when propofol is used, the sedation will be managed by a specialist doctor trained in anesthesia.

The purpose of the study is to compare these two sedation approaches to see which one works better and is safer during endoscopic ultrasound procedures. Patients participating in the study will be randomly assigned to receive either remimazolam or propofol for their sedation. The study will look at whether patients experience any problems with their heart or breathing during the procedure, such as low oxygen levels, changes in blood pressure, irregular heartbeat, or changes in heart rate. The medications will be given through a vein, and remimazolam can be given up to a total of 33 milligrams while propofol will be given at a rate based on the patient's weight.

The study will also examine other aspects of the sedation experience, including how satisfied patients and doctors are with the quality of sedation, how long it takes to start the procedure, how quickly patients wake up afterward, how much time is spent in the recovery area, and whether any additional medications are needed. The study will track if patients experience pain when the medication is injected, whether they need to stay in the hospital, and whether any breathing support is required. Information will also be collected about the costs of the different sedation approaches, including the price of medications, staff time, and how long the procedure rooms are occupied.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Assignment to treatment group
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures fairness in the study.
One group will receive remimazolam for sedation, administered by the doctor performing the procedure.
The other group will receive propofol for sedation, administered by an anesthesia specialist.
Step 2
Preparation for the procedure
Before the Endoscopic Ultrasound procedure begins, your vital signs will be measured. These include blood pressure, heart rate, and oxygen levels in your blood.
An intravenous line will be placed in your vein to allow the sedation medication to be given.
You will receive oxygen through a mask or nasal tube during the procedure.
Step 3
Administration of sedation medication
You will receive sedation medication through the intravenous line. The medication will be given as an intravenous infusion, which means it will flow slowly into your vein.
If you are in the remimazolam group, the doctor performing the endoscopy will manage your sedation.
If you are in the propofol group, an anesthesia specialist will manage your sedation.
The sedation will make you deeply relaxed and sleepy during the procedure.
Step 4
Endoscopic Ultrasound procedure
While you are sedated, the doctor will perform the Endoscopic Ultrasound procedure. This involves inserting a flexible tube with a camera and ultrasound device through your mouth to examine your digestive system.
Throughout the procedure, your heart rate, blood pressure, and oxygen levels will be continuously monitored.
If needed, additional sedation medication or other supportive treatments may be given to ensure your safety and comfort.
Step 5
Recovery after the procedure
After the procedure is completed, you will be moved to a recovery area.
The medical staff will monitor you until you wake up and your vital signs are stable.
The time spent in the recovery room will be recorded as part of the study.
Step 6
Evaluation and discharge
Once you are fully awake and meet the discharge criteria, you will be allowed to leave the hospital.
You will be asked questions about your experience with the sedation and the procedure. This helps evaluate the quality of sedation from your perspective.
The doctor will also provide their evaluation of the sedation quality.
The total time from the end of the procedure until you are discharged will be recorded.

Who can join the trial?

4 criteria

You must be older than 18 years of age
You must be scheduled for a planned EUS procedure, which is a test where a doctor uses a special camera with sound waves to look at your digestive system from the inside
You must sign a document showing that you agree to take part in the study after being informed about it, called informed consent
Your procedure must be done as an outpatient, which means you will go home the same day and will not need to stay overnight in the hospital

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified for this clinical trial in the provided information.

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Ospedale San Raffaele S.r.l.
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Milan, Italy

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Investigated drugs

Remimazolam
is a sedative medication used to help patients relax and sleep during medical procedures. In this trial, it will be given to put patients into a deep sleep while doctors perform an examination of the digestive system using a special ultrasound device.
Propofol
is a sedative medication commonly used to make patients sleep during medical procedures. In this trial, it will be used to provide deep sedation so patients remain comfortable and unaware during the examination of their digestive system.

What is already known about the treatment

Remimazolam
Remimazolam is a short-acting sedative medication given through an injection into a vein (intravenous administration) to help patients relax and sleep during medical procedures. It belongs to a class of drugs called benzodiazepines, which work by enhancing the calming effects of a natural brain chemical called GABA (gamma-aminobutyric acid) that slows down nerve activity. This medication is used for procedural sedation, meaning it helps keep patients comfortable and still during diagnostic tests like endoscopic ultrasound examinations. Remimazolam is currently being studied in clinical trials and is approved in some countries as an alternative to other sedation medications because it works quickly and wears off rapidly after the procedure ends.
Propofol
Propofol is a widely used anesthetic medication administered through an injection into a vein (intravenous route) to produce deep sedation or general anesthesia during medical procedures and surgeries. It works by acting on specific receptors in the brain called GABA receptors, which helps to reduce brain activity and induce a state of unconsciousness or deep relaxation. This medication belongs to the pharmacological class of general anesthetics and sedative-hypnotics, and it has been a standard choice in medical practice for many years due to its rapid onset and quick recovery time. Propofol is commonly used by anesthesiologists for various procedures, including endoscopic examinations, because patients typically wake up quickly with minimal drowsiness after the medication is stopped.

Investigated diseases

Gastric Cancer
Gastric cancer is a disease where abnormal cells grow uncontrollably in the lining of the stomach. The disease typically begins in the inner layer of the stomach wall and can gradually spread deeper into the stomach tissues. In early stages, the cancer may cause few or no symptoms, making it difficult to detect. As the disease progresses, the cancerous cells can invade surrounding tissues and organs. The abnormal growth may also spread to nearby lymph nodes. Advanced stages involve the cancer spreading to distant parts of the body through the bloodstream or lymphatic system.
Pancreatic Cancer
Pancreatic cancer occurs when cells in the pancreas, an organ located behind the stomach, begin to grow abnormally and form a tumor. The disease most commonly starts in the cells that line the ducts of the pancreas. In its early stages, pancreatic cancer rarely causes symptoms, which makes early detection challenging. As the tumor grows, it can block the bile duct or interfere with the pancreas's normal functions. The cancer cells may invade nearby blood vessels, nerves, and other organs. In later stages, the disease can spread to the liver, lungs, and other distant organs.