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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Di Pisa Pisa Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
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Anpkooo Unxjs Svpwndjtr Lgbpkd Dj Bxdjpoy Bologna Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
30.09.2020

Trial locations

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.

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 ID:
2024-512385-34-00
Protocol code:
TREX
NCT ID:
NCT03089905
Trial Phase:
Therapeutic confirmatory (Phase III)

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