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Study of Fast Awakening from General Anesthesia Using a Drug Combination Including Remimazolam in Healthy Volunteers

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 healthy volunteers undergoing general anesthesia, which is a medical state where a person is temporarily unconscious and unable to feel pain during medical procedures. The study will use several medications including remimazolam, a medicine that causes sedation and sleep, sufentanil citrate, a strong pain reliever, and rocuronium bromide, which relaxes muscles. Additional medications will be used to reverse the effects of anesthesia, including sugammadex sodium to reverse muscle relaxation, naloxone hydrochloride to reverse the effects of pain medication, and flumazenil to reverse sedation.

The purpose of this study is to investigate how long it takes and how well rapid sequence emergence from general anesthesia works, which means bringing someone quickly out of the sleep-like state caused by anesthesia. The study will measure several things during this process, with the main focus being on how long it takes for spontaneous breathing to return, meaning when the person starts breathing on their own again without help. Other measurements will include the time it takes for the person to open their eyes, when reflexes like swallowing and coughing come back, breathing patterns including oxygen levels and breathing rate, heart rate and blood pressure, brain activity levels, the depth of muscle relaxation, and the total time needed to become fully awake as before the anesthesia was given.

During the study, healthy volunteers will receive general anesthesia using the combination of medications mentioned above. The medications will be given through an injection into a vein. After the anesthesia is established, the reversal medications will be administered to bring the volunteers out of anesthesia in a controlled manner. Throughout this process, various measurements will be taken to track how quickly and smoothly the volunteers wake up from the anesthesia and return to their normal state.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial anesthesia administration

    Your participation in the study begins when general anesthesia is administered to you.

    The anesthesia will be given through an intravenous line, which means the medications will be delivered directly into your vein.

    Several medications will be used to induce anesthesia, including remimazolam (a sedative medication), sufentanil citrate (a pain relief medication), and rocuronium bromide (a muscle relaxant).

    These medications will put you into a state of general anesthesia where you will be unconscious and unable to feel pain.

  2. Step 2

    Monitoring during anesthesia

    While you are under anesthesia, various measurements will be taken to monitor your condition.

    Your blood pressure and heart rate will be continuously monitored to track your cardiovascular system.

    Your oxygen saturation, breathing rate, and carbon dioxide levels will be measured to assess your respiratory function.

    A Bispectral Index Score, also called BIS, will be recorded. This is a measurement that indicates the depth of your anesthesia by monitoring your brain activity.

    The depth of neuromuscular block will be assessed. This measures how much your muscles are relaxed by the medication.

  3. Step 3

    Rapid emergence procedure

    After the anesthesia phase, a rapid emergence procedure will be initiated to reverse the effects of anesthesia.

    You will receive sugammadex sodium through your intravenous line. This medication reverses the muscle relaxation caused by rocuronium bromide.

    You will also receive flumazenil, which reverses the sedative effects of remimazolam.

    Additionally, naloxone hydrochloride will be administered to reverse the effects of the pain relief medication sufentanil.

    All these reversal medications will be given as injections directly into your vein.

  4. Step 4

    Recovery and observation

    After the reversal medications are given, various aspects of your recovery will be observed and timed.

    The time it takes for your spontaneous breathing to return will be recorded. This means breathing on your own without assistance.

    The time until you open your eyes will be measured.

    The return of your airway reflexes, such as swallowing and coughing, will be monitored and timed.

    Your respiratory function, including oxygen saturation, breathing rate, and carbon dioxide levels, will continue to be monitored.

    Your cardiovascular parameters, including blood pressure and heart rate, will be continuously observed.

    The Bispectral Index Score will continue to be measured to assess your level of consciousness.

    The depth of neuromuscular block will be assessed to ensure muscle function is returning to normal.

    The total time until you are fully awake and in the same condition as before the anesthesia was given will be recorded.

Who can join the trial?

4 criteria

  • You must be between 18 and 65 years old
  • You must have an ASA score of II or lower, which means you either have no long-term health problems or only mild health problems that do not limit your daily activities
  • You must not have any serious ongoing diseases affecting your heart, lungs, liver, or kidneys
  • You must not have epilepsy, which is a condition that causes seizures or fits

Who cannot join the trial?

1 criterion

  • Exclusion criteria information is not available for this clinical trial
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Investigated drugs

General Anaesthesia is a medication that causes you to fall into a deep sleep so you don't feel pain during surgery or medical procedures. In this trial, doctors are studying how quickly and safely patients can wake up from this type of anaesthesia.

What is already known about the treatment

  • Sugammadex sodium

    This medication is an injectable solution used to quickly reverse the effects of muscle relaxants during surgery. It is currently widely used in clinical practice to help patients regain muscle control after anesthesia. It works by binding directly to certain muscle relaxant molecules in the blood, effectively trapping them so they cannot affect the muscles. This drug is classified as a selective relaxant binding agent.

  • Naloxone hydrochloride

    This is an injectable solution used primarily to reverse the effects of opioid medications, such as pain relievers, in cases of overdose. It is a standard, well-established treatment in emergency medicine and hospitals. On a molecular level, it works by blocking the receptors in the brain that opioids normally attach to, preventing the drug from working. This medication is classified as an opioid antagonist.

  • Flumazenil

    Administered through an intravenous injection, this medication is used to reverse the sedative effects of certain drugs like benzodiazepines. It is a common and established treatment used to wake patients up or treat accidental overdoses. It works by competing with these sedative drugs for the same binding sites in the brain, essentially pushing the sedative molecules away. This drug is classified as a benzodiazepine receptor antagonist.

  • Remimazolam

    This is an injectable medication used to induce and maintain sedation or general anesthesia. It is a newer type of sedative currently used in clinical settings to help patients remain asleep during medical procedures. It works by enhancing the effect of a natural calming chemical in the brain, which helps to slow down brain activity. This substance is classified as a benzodiazepine sedative.

  • Sufentanil citrate

    This medication is an injectable solution used to provide strong pain relief, often during surgery. It is a highly potent and well-known drug used extensively in anesthesia and intensive care. It works by attaching to specific receptors in the nervous system that block the transmission of pain signals to the brain. This drug is classified as a potent opioid analgesic.

  • Rocuronium bromide

    This is an injectable medication used to temporarily paralyze muscles during surgery or medical procedures to make them easier to perform. It is a standard part of anesthesia used to prevent muscle movement. It works by blocking the signals from nerves to the muscles, preventing the muscles from receiving the command to contract. This drug is classified as a non-depolarizing muscle relaxant.

Investigated diseases

General Anesthesia – General anesthesia is a medically induced state of temporary unconsciousness and loss of sensation throughout the entire body. It is used during surgical procedures to ensure patients do not feel pain or have awareness of the operation. The process involves administering medications that affect the central nervous system, causing the patient to lose consciousness and reflexes. During general anesthesia, vital functions such as breathing may need support, and the depth of unconsciousness is carefully monitored. As the anesthetic medications are stopped or reversed, the patient gradually emerges from this state. The emergence phase involves the return of spontaneous breathing, airway reflexes, consciousness, and full awakening to the pre-anesthesia state.
Trial detailsLast updated 3 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2024-516415-24-03Estimated enrolment10 patientsSponsorRadboud universitair medisch centrum Stichting

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