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Study on the Effects of Dexmedetomidine and Midazolam on Children's Experience After General Anesthesia

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What is this trial about?

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

This clinical trial is focused on understanding how certain medications affect children's experiences after undergoing general anesthesia. The study involves children who are between 7 and 18 years old and are scheduled for surgery that requires general anesthesia. The medications being studied include DEXMEDETOMIDINE EVER PHARMA, which is a solution used for infusion, and MIDAZOLAM VIATRIS, which is a solution for injection or infusion. Additionally, a placebo, which is a non-active substance, will be used for comparison. The purpose of the study is to assess how these medications, used as premedication, impact the children's experience during the perioperative period, which is the time surrounding the surgery.

During the study, children will receive one of the medications or the placebo before their surgery. Researchers will then observe and record various aspects of the children's experiences, such as their level of anxiety, any changes in heart rate or blood pressure, pain after the surgery, and how quickly they recover from anesthesia. The study will also look at whether the medications affect memory, behavior, and overall quality of life after the surgery. The main focus is on the children's self-reported experiences 24 hours after the surgery or before they leave the hospital if they are outpatients.

The trial aims to provide valuable insights into how these medications can improve the surgical experience for children by reducing anxiety and other negative effects associated with surgery and anesthesia. By understanding these effects, healthcare providers can make better-informed decisions about premedication for children undergoing surgery, potentially leading to improved outcomes and comfort for young patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, which is to assess the impact of medication on children's experience during surgery under general anesthesia.

    You will be asked to confirm your eligibility, which includes being between 7 and 18 years old, needing surgery under general anesthesia, and being able to complete a self-questionnaire.

  2. Step 2

    Pre-surgery preparation

    Before your surgery, you will receive a medication. This could be either Dexmedetomidine, a placebo (a syrup that looks like medicine but has no active ingredients), or Midazolam.

    Dexmedetomidine is given as a solution to be diluted for infusion, while Midazolam is provided as a solution for injection or infusion.

  3. Step 3

    During surgery

    During the surgery, your experience will be monitored, including any changes in anxiety, heart rate, blood pressure, and pain levels.

    The time it takes for you to wake up from anesthesia and your recovery rate will also be observed.

  4. Step 4

    Post-surgery evaluation

    After the surgery, you will be asked to complete a questionnaire about your experience. This will happen 24 hours after the surgery or before you leave the hospital if you are an outpatient.

    Your responses will help measure the primary outcome of the study, which is your perioperative experience score.

  5. Step 5

    Follow-up

    Additional observations will be made regarding any anxiety, memory issues, or changes in behavior after the surgery.

    Your quality of life and any complications during the perioperative period will also be assessed.

Who can join the trial?

4 criteria

  • Children who are older than 7 years old and younger than 18 years old.
  • Children who need to have surgery with general anesthesia (a type of medicine that makes you sleep during surgery).
  • Children who can fill out a self-questionnaire (a form they can complete by themselves).
  • Children who need a procedure that requires general anesthesia.

Who cannot join the trial?

2 criteria

  • Patients who are not suitable for general anesthesia cannot participate. General anesthesia is a type of medicine that makes you completely unconscious and unable to feel pain during surgery.
  • Patients who cannot have sedative or anxiolytic sedation are excluded. Sedatives are medicines that help you relax or sleep, and anxiolytics are medicines that reduce anxiety.
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Investigated drugs

  • Sedative Medication

    is used to help children feel calm and relaxed before they undergo general anesthesia. This medication helps reduce anxiety and stress, making the experience less frightening for young patients. It works by slowing down the brain's activity, which helps the child feel more at ease and comfortable before the procedure.

  • Anxiolytic Medication

    is designed to specifically target and reduce feelings of anxiety in children who are about to have surgery. This type of medication helps to ease nervousness and fear, allowing the child to feel more secure and less worried. It acts on certain chemicals in the brain to help manage anxiety levels, providing a smoother and more pleasant experience for the child during the perioperative period.

What is already known about the treatment

General anesthesia and sedative and anxiolytic sedation – This medication is administered to help patients, particularly children, feel calm and relaxed before undergoing surgery. It is given as a sedative to ease anxiety and as an anesthetic to ensure the patient does not feel pain during the procedure. Currently, this medication is widely used in medical practice and is well-documented in medical literature. Its main purpose is to provide a smooth and stress-free experience for children undergoing surgery. At the molecular level, it works by affecting certain chemicals in the brain to induce relaxation and prevent pain. It is classified pharmacologically as both a sedative and an anesthetic.

Investigated diseases

  • General Anesthesia

    General anesthesia is a medically induced state of unconsciousness with loss of protective reflexes, resulting from the administration of one or more anesthetic agents. It is used to allow patients to undergo surgery and other procedures without pain or distress. During general anesthesia, the patient is completely unaware and does not feel pain. The progression involves the induction phase, where the patient loses consciousness, followed by the maintenance phase, where anesthesia is sustained throughout the procedure. After the procedure, the patient enters the emergence phase, where the effects of the anesthetic agents are reversed, and consciousness is gradually regained. The process is carefully monitored to ensure the patient's safety and comfort.

  • Perioperative Anxiety

    Perioperative anxiety refers to the feelings of nervousness, fear, or apprehension that a patient may experience before, during, or after a surgical procedure. This anxiety can arise from concerns about the surgery itself, potential pain, or the outcome of the procedure. It can manifest as physical symptoms such as increased heart rate, sweating, or trembling. The progression of perioperative anxiety can vary, with some patients experiencing heightened anxiety as the surgery approaches, while others may feel more anxious during the recovery period. Managing this anxiety is important to ensure a smoother surgical experience and recovery. It is a common experience and can affect patients of all ages.

  • Postoperative Pain

    Postoperative pain is the discomfort or pain that occurs after a surgical procedure. It is a normal part of the healing process as the body responds to the surgical intervention. The intensity and duration of postoperative pain can vary depending on the type of surgery, the patient's pain threshold, and other individual factors. Initially, the pain may be more intense and gradually decrease as the healing progresses. Effective management of postoperative pain is crucial to aid recovery and improve the patient's overall experience. It is typically monitored and addressed by healthcare providers to ensure patient comfort.

  • Cognitive Impairment

    Cognitive impairment refers to difficulties with thinking, memory, and other mental functions. It can occur as a temporary condition following surgery or anesthesia, affecting the patient's ability to concentrate, remember, or make decisions. The progression of cognitive impairment can vary, with some individuals experiencing mild and short-lived symptoms, while others may have more pronounced difficulties. Factors such as age, type of surgery, and pre-existing health conditions can influence the extent of cognitive impairment. It is important to monitor and address these changes to support the patient's recovery. Cognitive function typically improves as the patient recovers from the surgical procedure.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501124-23-00Protocol codeRECHMPL21_0354Estimated enrolment1 000 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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