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Study of Ketamine Alone and Ketamine-Propofol Combination Compared to Propofol for Rapid Sequence Induction in Operating Room Patients at Risk of Aspiration

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on finding the best medication for rapid sequence induction, which is a medical procedure used to quickly make patients unconscious before surgery when there is a risk of stomach contents entering the lungs. The study compares three different approaches: using propofol alone (a commonly used anesthetic medication), using ketamine alone, or using a combination of both medications.

The purpose of this research is to determine which of these medication options works best for safely putting patients to sleep and placing a breathing tube, while maintaining stable blood pressure. The medications will be given through an intravenous injection, which means they are delivered directly into a vein. The study will look at how well each medication option works in helping doctors successfully place the breathing tube on the first try without causing a dangerous drop in blood pressure.

During the study, patients will receive one of the three medication options before their planned surgery. The medical team will monitor vital signs including blood pressure, heart rate, and oxygen levels for 10 minutes after giving the medication. Patients will also be checked for any side effects while in the recovery room after surgery and for up to one week afterward.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment in operating room

    Your vital signs will be measured, including blood pressure, heart rate, and oxygen levels

    Medical staff will confirm your fasting status and risk factors for aspiration

  2. Step 2

    Pre-oxygenation phase

    You will receive oxygen through a mask before the procedure begins

    Your vital signs will continue to be monitored every minute

  3. Step 3

    Anesthetic administration

    You will receive one of three possible anesthetic combinations through an intravenous injection:

    Option 1: Propofol alone

    Option 2: Ketamine alone

    Option 3: Combination of ketamine and propofol

  4. Step 4

    Breathing tube placement

    Medical staff will place a breathing tube in your airway

    This process is called tracheal intubation

    Your vital signs will be monitored every minute for 10 minutes after receiving the anesthetic

  5. Step 5

    Recovery room monitoring

    After the procedure, you will be transferred to the recovery room

    Medical staff will monitor your condition and assess your recovery

    Your mental status will be evaluated using a standardized assessment

  6. Step 6

    Follow-up period

    Your health status will be monitored for 7 days after the procedure

    Medical staff will check for any complications or side effects

    This monitoring includes checking for heart-related complications and overall recovery

Who can join the trial?

14 criteria

  • Must be between 18 and 80 years old
  • Can be either female or male
  • Must have at least one risk factor for stomach content aspiration (breathing in stomach contents), which includes:
    • Less than 6 hours of fasting before surgery
    • Intestinal blockage
    • Decreased bowel movement
    • Vomiting in the last 12 hours
    • Orthopedic injury in the last 12 hours
    • History of acid reflux
    • Hiatal hernia (stomach bulging into chest cavity)
    • Slow stomach emptying
    • Previous stomach surgery affecting muscle function
    • Continued use of certain diabetes medications (GLP1 analogues)
    • Must need a breathing tube placement during general anesthesia in the operating room
    • Must provide written informed consent (either from patient or next of kin in emergency cases)

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years
  • Known allergy or hypersensitivity to ketamine, propofol, or any components of these medications
  • Presence of cardiovascular diseases (heart conditions)
  • Uncontrolled hypertension (high blood pressure)
  • History of psychiatric disorders or psychosis
  • Current pregnancy or breastfeeding
  • Raised intracranial pressure (increased pressure inside the skull)
  • Severe liver dysfunction (problems with liver function)
  • Severe kidney dysfunction (problems with kidney function)
  • Participation in another clinical trial within the past 30 days
  • Inability to provide informed consent
  • History of seizures (fits or convulsions)
  • Unstable medical condition that could interfere with the study procedures
  • Known drug or alcohol abuse
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Investigated drugs

  • Ketamine

    is a fast-acting anesthetic medication used to put patients to sleep before surgery. It helps maintain stable blood pressure during medical procedures and is particularly useful in emergency situations. It can be used alone or in combination with other medications.

  • Propofol

    is a commonly used intravenous anesthetic that quickly induces sleep. It is considered a standard medication for putting patients to sleep before surgery. It works rapidly but may cause a drop in blood pressure in some patients.

  • Ketamine-Propofol combination

    (sometimes called "Ketofol") combines the benefits of both medications. This combination aims to provide effective anesthesia while potentially reducing the side effects that might occur when either medication is used alone. The combination may offer better stability of blood pressure during medical procedures.

What is already known about the treatment

  • Propofol

    A fast-acting intravenous anesthetic medication used primarily for the induction and maintenance of general anesthesia during surgery. This drug works by enhancing the effects of GABA neurotransmitters in the brain, leading to rapid sedation and unconsciousness. It belongs to the class of drugs known as sedative-hypnotics and is particularly valued in rapid sequence induction due to its quick onset and short duration of action.

  • Ketamine

    An injectable anesthetic medication that provides both pain relief and sedation, commonly used for induction of anesthesia, especially in emergency situations. It works differently from most anesthetics by blocking NMDA receptors in the brain, creating a dissociative anesthetic state while maintaining respiratory function and blood pressure. This medication belongs to the class of dissociative anesthetics and is particularly useful in patients where hemodynamic stability is crucial.

  • Ketamine-Propofol Combination

    A mixture of two anesthetic medications that combines the rapid sedation properties of propofol with the analgesic and hemodynamic stability benefits of ketamine. This combination, sometimes called "ketofol," is administered intravenously and provides balanced anesthesia with fewer side effects than either drug alone. The combination is particularly valuable in rapid sequence induction as it maintains stable blood pressure while providing effective sedation.

Investigated diseases

Based on the provided source data, there is one main medical condition to describe: Aspiration of gastric contents - A condition where stomach contents move up into the airways and lungs. It occurs when the natural protective mechanisms of the throat and upper airway fail to prevent stomach contents from entering the lungs. This condition commonly develops during unconsciousness, severe illness, or when normal reflexes are impaired. The stomach contents can include food, liquid, or digestive juices. The condition can develop rapidly and is often associated with situations requiring emergency medical procedures. Note: The trial focuses on preventing this condition during rapid sequence induction in the operating room, but as per instructions, I've omitted treatment and diagnostic aspects.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517582-16-00Protocol codeRC24_0389Estimated enrolment1 218 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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