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Study on the Effects of Low-Dose Sevoflurane, Dexmedetomidine, and Remifentanil Anesthesia on Neurodevelopment in Children Under 2 Undergoing Long Surgeries

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 clinical trial is focused on young children under the age of 2 who are undergoing surgery that lasts at least 2 hours. The study is examining the effects of different types of anesthesia on the long-term brain development of these children. The trial compares the use of a standard dose of sevoflurane, which is a common anesthetic, with a combination of low-dose sevoflurane, dexmedetomidine hydrochloride, and remifentanil. The goal is to determine which approach is better for the children's cognitive development, which refers to their ability to think, learn, and remember, as they grow older.

During the study, children will receive either the standard dose of sevoflurane or the combination of low-dose sevoflurane, dexmedetomidine hydrochloride, and remifentanil while they are under anesthesia for their surgery. The researchers will then assess the children's cognitive development at the age of 3 using a test called the Wechsler Preschool and Primary School Intelligence Scale, which measures intelligence. The study aims to see if the combination of drugs leads to better outcomes in terms of the children's overall cognitive function compared to the standard treatment.

The trial will also monitor other aspects such as language skills, attention, memory, and behavior, as well as the safety of the anesthesia methods used. This includes checking for any side effects or complications during and after the surgery. The study is expected to provide valuable information on how different anesthesia methods might impact the long-term development of young children who need surgery.

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

    Joining the study

    The study involves children under the age of 2 years who are scheduled for surgery lasting at least 2 hours. The types of surgeries include craniofacial, thoracic, abdominal, urologic, orthopaedic, and neurosurgical procedures.

    The main objective is to compare the effects of low-dose sevoflurane, dexmedetomidine, and remifentanil anaesthesia with standard dose sevoflurane anaesthesia on cognitive function.

  2. Step 2

    Anaesthesia administration

    During the surgery, anaesthesia will be administered. The study compares two groups: one receiving standard dose sevoflurane via inhalation, and the other receiving a combination of low-dose sevoflurane, dexmedetomidine via infusion, and remifentanil.

    The anaesthesia is expected to last between 2 to 6 hours, depending on the surgery.

  3. Step 3

    Post-operative monitoring

    After the surgery, monitoring will occur to assess recovery time, incidence of intra-operative hypotension, bradycardia, and post-operative pain using the FLACC Scale (Face, Legs, Activity, Cry, Consolability Scale).

    Safety will be evaluated by recording any adverse events or serious adverse events.

  4. Step 4

    Follow-up assessments

    At 3 years of age, the child's cognitive function will be assessed using the full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale.

    Additional neuropsychological tests will evaluate language, attention, memory, adaptive behaviour, and clinical behaviour.

Who can join the trial?

8 criteria

  • The child must be younger than 2 years old.
  • The child is scheduled for anaesthesia that is expected to last at least 2 hours, or the total time in the operating room is planned to be at least 2.5 hours, but not more than 6 hours.
  • The type of surgery the child is having must be one of the following:
    • Craniofacial surgery, such as surgery for a cleft lip or certain skull conditions.
    • Thoracic surgery, like surgery for lung malformations or a specific type of diaphragmatic hernia.
    • Abdominal surgery, such as surgery for Hirschsprung disease or Meckel's diverticulum.
    • Urologic surgery, like surgery for hypospadias or kidney repair using laparoscopy or robotics.
    • Orthopaedic surgery, such as surgery for congenital hip dislocation or clubfoot.
    • Neurosurgical surgery, like surgery for spine tethering or brachial plexus repair.

Who cannot join the trial?

2 criteria

  • Children who are not under the age of 2 years.
  • Children who are not having surgery that lasts at least 2 hours.
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Investigated drugs

  • Sevoflurane

    is a medication used to keep patients asleep during surgery. In this trial, it is used in two different ways: a standard dose and a low dose. The goal is to see if using a lower dose of sevoflurane, combined with other medications, is better for the brain development of young children.

  • Dexmedetomidine

    is a medication that helps to calm and sedate patients. It is used in this trial as part of a combination with low-dose sevoflurane to see if it can provide effective anesthesia while being gentler on the brain development of young children.

  • Remifentanil

    is a strong pain medication used during surgery. In this trial, it is combined with low-dose sevoflurane and dexmedetomidine to see if this combination can provide safe and effective anesthesia for young children, while also being better for their brain development.

What is already known about the treatment

  • Sevoflurane

    Sevoflurane is administered as an inhalation anesthetic, typically delivered through a vaporizer in an operating room setting. It is widely used in medical practice for inducing and maintaining general anesthesia, especially in pediatric patients. The main therapeutic indication is to provide anesthesia during surgeries. At the molecular level, sevoflurane works by enhancing the activity of inhibitory neurotransmitters in the brain, leading to a decrease in neuronal activity and resulting in loss of consciousness. It is classified as a volatile anesthetic agent.

  • Dexmedetomidine

    Dexmedetomidine is administered intravenously and is used in medical settings to provide sedation and analgesia. It is currently recognized in medical literature for its ability to sedate patients without causing significant respiratory depression. The main therapeutic indication is to provide sedation during surgeries or in intensive care settings. At the molecular level, dexmedetomidine acts as an agonist on alpha-2 adrenergic receptors, which leads to reduced sympathetic activity and sedation. It is classified as a sedative and analgesic agent.

  • Remifentanil

    Remifentanil is administered intravenously and is used in medical settings to provide pain relief and sedation during surgeries. It is well-documented in medical literature for its rapid onset and short duration of action, making it suitable for procedures requiring quick recovery. The main therapeutic indication is to provide analgesia during surgeries. At the molecular level, remifentanil acts as an agonist on mu-opioid receptors, leading to pain relief and sedation. It is classified as an opioid analgesic.

Investigated diseases

  • Intra-operative Hypotension

    This condition occurs when blood pressure drops significantly during surgery. It can lead to reduced blood flow to vital organs, potentially causing complications. The body may not receive enough oxygen and nutrients, which can affect organ function. It is often monitored closely during surgical procedures to ensure patient safety. The condition can be temporary and usually resolves once the underlying cause is addressed.

  • Intra-operative Bradycardia

    This condition is characterized by a slower than normal heart rate during surgery. It can result from various factors, including the effects of anesthesia or surgical manipulation. A slow heart rate can lead to decreased cardiac output, affecting blood flow to the body. It is important to monitor and manage this condition to maintain adequate circulation. Bradycardia during surgery is often transient and can be corrected with appropriate interventions.

  • Post-operative Pain

    This condition refers to the discomfort or pain experienced by patients after undergoing surgery. It can vary in intensity and duration depending on the type of surgery and individual pain tolerance. Effective pain management is crucial to aid recovery and improve patient comfort. Pain is typically assessed using scales that evaluate different aspects of the patient's experience. Proper management can help reduce complications and promote healing.

  • Adverse Events

    These are unexpected medical occurrences that happen during or after medical treatment or surgery. They can range from mild to severe and may or may not be directly related to the procedure. Monitoring and reporting adverse events are essential for patient safety and improving medical practices. Understanding the nature and frequency of these events helps in developing strategies to minimize risks. Adverse events are an important consideration in clinical trials and medical research.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512385-34-00Protocol codeTREXEstimated enrolment450 patientsSponsorIRCCS Istituto Giannina Gaslini

sourced from the EU Clinical Trials Register and site verification

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