Study of Propofol and Thiopental for anesthesia induction in newborns under 47 weeks postmenstrual age

3 1 1 1

What is this study about?

This research study focuses on finding the right dose of anesthesia medications for newborns who need general anesthesia. The study examines two different anesthetic medications: propofol and thiopental, which are given through a vein to make patients unconscious before medical procedures.

The purpose of this study is to determine the most effective dose of these medications for newborn babies who are less than 47 weeks post-conception age. Both medications are given as an injection into a vein, with propofol being administered as an infusion solution and thiopental as an injection solution. The maximum single dose of propofol used in the study is 3 mg per kilogram of body weight, while thiopental is used at up to 5 mg per kilogram of body weight.

During the study, medical staff will carefully monitor how newborns respond to these medications when they are given before surgery or other medical procedures requiring general anesthesia. The medications will be administered just once during the procedure, and doctors will observe how quickly and effectively they work to make the baby unconscious safely.

1 Initial anesthesia preparation

Your medical condition will be evaluated to confirm you meet the study criteria as a newborn under 47 weeks postmenstrual age requiring general anesthesia.

The medical team will prepare either thiopental sodium or propofol for intravenous administration.

2 Medication administration

You will receive either thiopental sodium solution or propofol emulsion through an intravenous line (a small tube inserted into your vein).

The medication will be given as a single dose to induce anesthesia (make you fall asleep).

3 Monitoring response

The medical team will observe your response to the medication.

They will check for loss of eyelash reflex (when your eyelashes no longer react to touch).

They will also assess your acceptance of a face mask for continued anesthesia delivery.

4 Completion of procedure

Once the appropriate level of anesthesia is achieved, your scheduled medical procedure will be performed.

The entire study period continues until December 31, 2028, but your individual participation ends after your procedure is complete.

Who Can Join the Study?

Patient must be a newborn baby (neonate) with a developmental age less than 47 weeks since conception (postmenstrual age)
Patient must be scheduled to receive general anesthesia (medication that puts you into a sleep-like state during a medical procedure)
Both male and female babies can participate
The medical condition requiring anesthesia can be of any type
Patient’s parent or legal guardian must be able to provide informed consent for participation in the study
Patient must be healthy enough to receive either propofol or thiopental (medications used to induce sleep during anesthesia)

Who Cannot Join the Study?

Known allergies or previous adverse reactions to propofol, thiopental, or any similar anesthetic medications
Premature babies with postmenstrual age less than 47 weeks (postmenstrual age is the time from the first day of the last menstrual period to birth plus the time after birth)
Babies with severe heart conditions or unstable heart function
Babies with significant breathing problems requiring intensive respiratory support
Infants with genetic disorders that might affect their response to anesthesia
Babies with serious liver or kidney problems that could affect how their body processes medications
Infants participating in other clinical trials at the same time
Babies whose parents or legal guardians have not provided informed consent for participation in the study
Infants with neurological conditions that might affect their response to anesthesia
Babies with severe infections or other acute medical conditions that could interfere with the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.11.2022

Trial locations

Investigated drugs:

Propofol is an intravenous anesthetic medication that helps patients fall asleep quickly before surgery. It is a white, milky liquid that is given through a vein. This medication works rapidly to induce sleep and is commonly used in general anesthesia, especially when quick onset is needed.

Thiopental is an ultra-short-acting barbiturate anesthetic medication given intravenously to make patients fall asleep before surgery. It works very quickly to induce sleep and has been used in anesthesia practice for many years. The medication is particularly known for its rapid onset of action when administered through a vein.

General Anesthesia in Neonates – A temporary state of controlled unconsciousness in newborn babies who have not yet reached 47 weeks post-conception age. During this condition, the baby is unable to feel pain and has no awareness or memory of surgical procedures. The state involves carefully controlled loss of protective reflexes, including the eyelash reflex, and acceptance of medical equipment such as face masks. This medical condition requires specialized care due to the unique physiology of newborns and their sensitivity to anesthetic medications.

Note: While this isn’t technically a disease but rather a medical condition/procedure, I’ve provided the description as requested, maintaining focus on the condition itself without discussing treatments or risks.

Trial ID:

2024-516072-15-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Propofol and Thiopental for anesthesia induction in newborns under 47 weeks postmenstrual age

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?