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Testing the effectiveness and safety of remimazolam, ketamine, and propofol for rapid sequence induction in patients at risk of aspiration

Verified siteRegistered drugNo placebo
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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 who need to have a breathing tube placed in their windpipe during surgery and who have at least one risk factor for stomach contents moving back up into the throat, which could cause serious breathing problems. The study will compare three different medications used to make patients unconscious before placing the breathing tube: remimazolam, propofol, and ketamine. All three medications will be given through a vein as an injection. The purpose of the study is to compare how well remimazolam works compared to standard doses of propofol and ketamine in allowing the breathing tube to be successfully placed on the first try in patients at risk of stomach contents moving up into the throat.

During the study, patients will receive one of the three medications to make them unconscious before the breathing tube is placed. The medical team will measure how successfully the breathing tube can be placed on the first attempt, which is the main goal of the study. They will also look at several other things during and after the procedure, including how easy it is to place the breathing tube, how long it takes to complete different steps of the process, and measurements of heart rate, blood pressure, and oxygen levels in the blood during the first five minutes after the medication is given. The team will check for any problems such as stomach contents moving into the lungs, low oxygen levels, changes in blood pressure or heart rate that require treatment, allergic reactions, and whether additional medications or fluids are needed.

After the procedure, patients will be monitored in the recovery room where the medical team will check for confusion or agitation and whether any calming medication is needed. For up to seven days after surgery, the study will track whether patients develop heart problems, kidney problems, or other serious complications, as well as survival rates. The study will help doctors understand whether remimazolam is as safe and effective as the other two medications currently used for this type of procedure.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and randomization

    After providing written informed consent, or if unable to do so, consent from your next of kin, or through an emergency procedure, you will be enrolled in the study.

    You will be randomly assigned to receive one of three medications for anesthesia: remimazolam, propofol, or ketamine.

  2. Step 2

    Pre-oxygenation in the operating room

    Before anesthesia begins, you will receive oxygen through a mask to prepare your body for the procedure.

    During this time, your heart rate, blood pressure, and oxygen levels in your blood will be monitored.

  3. Step 3

    Administration of anesthetic medication

    You will receive one of the three study medications through an intravenous injection (injection into a vein).

    The medication will be either remimazolam, propofol, or ketamine, depending on the group you were assigned to.

    This medication will put you to sleep for the surgery.

  4. Step 4

    Administration of muscle relaxant

    After the anesthetic medication, you will receive a neuromuscular blocking agent (a medication that temporarily relaxes your muscles) through an intravenous injection.

    This medication helps facilitate the insertion of a breathing tube.

  5. Step 5

    Insertion of breathing tube

    The anesthesiologist will insert a breathing tube through your mouth into your windpipe (a procedure called tracheal intubation).

    The medical team will assess how easily the tube can be inserted and whether it is successful on the first attempt.

  6. Step 6

    Monitoring during the first five minutes

    During the first five minutes after the anesthetic medication is given, your vital signs will be closely monitored every minute.

    This includes your heart rate, blood pressure, and oxygen saturation (the amount of oxygen in your blood).

    The medical team will observe for any complications such as low oxygen levels, changes in blood pressure, or irregular heartbeat.

    The time taken for each step of the anesthesia process will be recorded.

  7. Step 7

    Surgery and anesthesia maintenance

    Your surgery will proceed as planned under general anesthesia.

    The medical team will continue to monitor your condition and may administer additional medications as needed.

    Any use of medications to support your blood pressure or intravenous fluids will be recorded.

  8. Step 8

    Recovery room assessment

    After surgery, you will be transferred to the recovery room.

    Your mental state will be assessed using a specific scoring system to check for confusion or delirium (a state of mental confusion that can occur after anesthesia).

    If needed, you may receive medication to help with sedation or agitation.

  9. Step 9

    Follow-up until day seven

    You will be monitored for up to seven days after your surgery.

    The medical team will check for any complications related to your heart, kidneys, or overall recovery.

    Information about your survival and any major health events will be recorded.

Who can join the trial?

8 criteria

  • You must be between 18 and 80 years old
  • You must have at least one risk factor that increases the chance of aspiration, which means stomach contents could enter your lungs. These risk factors include:
    • You have not been without food for at least 6 hours before surgery
    • You have a blockage in your intestines or your intestines are not working properly
    • You have vomited within the last 12 hours
    • You have had a bone or joint injury within the last 12 hours
    • You have a history of stomach acid coming back up into your throat with symptoms, or a condition where part of your stomach pushes through your diaphragm, or your stomach empties too slowly, or problems with your nerves that control your stomach, or you have had surgery on your esophagus or stomach that affects the muscle that keeps food down
    • You need a breathing tube placed through your mouth into your windpipe during surgery while you are asleep
    • You or your family member must provide written permission to participate in the study, or an emergency procedure allows your participation

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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Investigated drugs

  • Remimazolam

    is a sedative medication that helps put patients to sleep before medical procedures. In this study, it is being tested to see how well it works for helping doctors insert a breathing tube into the windpipe.

  • Ketamine

    is an anesthetic medication used to make patients unconscious for surgery or procedures. It works quickly and is commonly used when doctors need to insert a breathing tube rapidly.

  • Propofol

    is a sedative medication that puts patients to sleep for surgery or medical procedures. It acts very quickly and is widely used to help patients become unconscious before a breathing tube is inserted.

What is already known about the treatment

  • Remimazolam

    Remimazolam is a short-acting sedative medication given through an intravenous injection (into a vein) and is used to put patients to sleep before surgery or medical procedures. It belongs to a class of drugs called benzodiazepines, which work by enhancing the calming effects of a natural chemical in the brain called GABA, helping to reduce brain activity and induce sleep quickly. This medication is particularly useful for rapid sequence induction, a technique used when patients need to be put to sleep very quickly to protect their airway, especially when there is a risk of stomach contents entering the lungs. Remimazolam is currently being studied in clinical trials and is approved in some countries as an alternative to other anesthetic agents because it works fast and wears off quickly after the procedure is finished.

  • Ketamine

    Ketamine is an anesthetic medication that can be given through injection into a vein or muscle, and it is used to induce sleep and provide pain relief during surgical procedures. It works differently from most anesthetics by blocking a specific receptor in the brain called the NMDA receptor, which helps produce a dissociative state where patients feel detached from their surroundings and experience reduced pain sensation. This medication is widely used in emergency and operating room settings, particularly for rapid sequence induction when patients need quick airway protection, because it maintains breathing reflexes and blood pressure better than some other anesthetics. Ketamine has been used in medical practice for many decades and is considered a safe and effective option, especially in patients who may be at risk for low blood pressure during anesthesia.

  • Propofol

    Propofol is a widely used anesthetic medication administered through intravenous injection (into a vein) to induce and maintain sleep during surgical procedures and medical interventions. It belongs to a class of medications called sedative-hypnotics and works by enhancing the activity of GABA, a natural brain chemical that slows down nerve signals, resulting in rapid loss of consciousness and sedation. This medication is the most commonly used agent for rapid sequence induction in operating rooms because it acts very quickly, typically putting patients to sleep within seconds, and wears off rapidly when the infusion is stopped. Propofol has been a standard medication in anesthesia practice for over three decades and is valued for its predictable effects and smooth recovery profile.

Investigated diseases

Rapid Sequence Induction – This is a medical procedure used in the operating room rather than a disease itself. It is a technique for quickly inducing anesthesia and securing the airway through tracheal intubation in patients who are at increased risk of aspiration. Aspiration occurs when stomach contents enter the airways and lungs, which can happen during anesthesia induction. The procedure involves administering medications to rapidly render the patient unconscious and relax their muscles to allow for swift placement of a breathing tube. This technique is particularly important for patients with full stomachs, bowel obstructions, or other conditions that increase the risk of regurgitation. The goal is to minimize the time between loss of consciousness and securing the airway to protect the lungs from gastric contents.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521602-18-00Protocol codeRC25_0093Estimated enrolment90 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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