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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Toulouse Toulouse France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nimes Nimes France
Fondation Lenval Nice Nice France
Csagjw Hskzuqlkkwe Ufuytjarzexse Rmhwt Reims France
Cegdkb Hezmhhewyvk Rcdzwrsd Dyvywwnztbvfnf Angers France
Hzxccbfx Uosbyfrnmqqnfh Sgcjltlhrt &kwhqci Hqmxeud df Hylahxthaqd STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
18.04.2023

Trial locations

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.

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 ID:
2022-501124-23-00
Protocol code:
RECHMPL21_0354
Trial Phase:
Therapeutic confirmatory (Phase III)

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