Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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

No specific medication identified – This clinical trial focuses on studying rapid sequence emergence from general anesthesia, which refers to the process of quickly and safely waking patients up after they have been put to sleep for surgery or medical procedures. The research aims to investigate how long it takes for patients to wake up and how effectively this can be done using various anesthetic techniques. General anesthesia works by temporarily affecting the brain and nervous system to cause loss of consciousness, pain relief, and muscle relaxation during medical procedures. The study does not specify particular anesthetic drugs but rather examines the overall process and timing of bringing patients back to consciousness after anesthesia.

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 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516415-24-03Estimated enrolment10 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.