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

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 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.

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

    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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

10 criteria

  • 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
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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.

What is already known about the treatment

  • Propofol

    A fast-acting intravenous anesthetic medication used for the induction and maintenance of general anesthesia, particularly in surgical procedures. This white, oil-based emulsion works by enhancing the effects of GABA neurotransmitters in the brain, leading to sedation and unconsciousness. It belongs to the class of medications known as sedative-hypnotics and is widely recognized for its quick onset and rapid recovery profile, making it particularly valuable in modern anesthesia practice.

  • Thiopental

    An ultra-short-acting barbiturate administered intravenously for the induction of general anesthesia, particularly useful in emergency surgeries and rapid sequence intubation. This medication works by depressing the central nervous system through enhancement of GABA receptor activity, leading to quick unconsciousness typically within 30-40 seconds after administration. It belongs to the barbiturate class of medications and has been a traditional choice for anesthesia induction, though its use has decreased in favor of newer alternatives like propofol in many clinical settings.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516072-15-00Estimated enrolment160 patientsSponsorOdense University Hospital

sourced from the EU Clinical Trials Register and site verification

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