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Evaluation of opioid use with nociceptive monitoring in intensive care patients receiving deep sedation with isoflurane, propofol, and midazolam

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 focuses on patients in intensive care units who require deep sedation. The study evaluates how monitoring pain levels affects the use of opioids in patients who need complete muscle relaxation. The medications used in the study include propofol and midazolam given through a vein, and isoflurane which is inhaled.

The study aims to compare different methods of sedation and pain control in critically ill patients who need both deep sedation and muscle relaxation. These patients are typically those with severe conditions requiring breathing support through mechanical ventilation, increased pressure in the brain, or continuous seizures. The study will monitor how different combinations of medications and monitoring methods affect the amount of pain medication needed.

During the study, patients will receive either intravenous sedation medications or inhaled sedation, along with pain medications. Some patients will have their pain levels monitored using a special device called NOL (Nociception Level) monitor, while others will receive standard care without this monitoring. The study will track various aspects of patient care, including breathing status, heart function, brain monitoring, and the development of any infections.

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 and preparation

    Upon admission to the Intensive Care Unit (ICU), your condition will be evaluated to confirm the need for deep sedation

    The medical team will verify that you meet all requirements, including the need for muscle relaxation and an expected ICU stay of at least 72 hours

  2. Step 2

    Medication administration

    You will receive sedative medications through an intravenous line or by inhalation. The medications may include propofol, midazolam, or isoflurane

    Muscle relaxant medication will be administered through an intravenous line. The dose will be monitored using a special device called Train-of-Four (TOF)

    Pain medication (opioids) will be given through an intravenous line as needed

  3. Step 3

    Continuous monitoring

    Your breathing, heart function, and brain activity will be constantly monitored

    A device may be used to measure your pain levels

    This monitoring will continue throughout your stay in the ICU

  4. Step 4

    Daily assessments

    The medical team will perform daily checks of your condition

    They will monitor for any side effects or complications

    Your medication doses may be adjusted based on these assessments

  5. Step 5

    Recovery phase

    When your condition improves, the medical team will begin reducing the medications

    Your recovery time will be monitored, including how long it takes you to wake up

    You will be checked for any confusion or disorientation during the awakening process

  6. Step 6

    Study completion

    The study will track your total time in the ICU and hospital

    Your overall recovery and any complications will be documented

    The study will continue monitoring your condition until you leave the hospital

Who can join the trial?

10 criteria

  • Must be at least 18 years old (both men and women can participate)
  • Must require deep sedation (a state of decreased consciousness where the patient is not easily awakened)
  • Must need muscle relaxation medication (medicines that cause temporary muscle paralysis) to help with:
    • Breathing machine support
    • Reducing oxygen use by the body
    • Managing high pressure in the brain
    • Controlling severe seizures
    • Must be expected to stay in the Intensive Care Unit (ICU) for at least 3 days
    • Must have signed informed consent - this can be provided by:
      • The patient themselves
      • A family member
      • A legal representative

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Patients with known allergies to any of the medications used in the study
  • Patients with severe kidney problems (impaired renal function)
  • Patients with severe liver disease (hepatic dysfunction)
  • Patients with uncontrolled high blood pressure (hypertension)
  • History of adverse reactions to sedatives or opioids
  • Pregnant or breastfeeding women
  • Patients with severe heart problems (cardiovascular disease)
  • Patients with unstable medical conditions that could interfere with sedation
  • Patients unable to provide informed consent
  • Participation in other clinical trials within the past 30 days
  • Patients with chronic pain conditions requiring regular opioid use
  • Patients with drug or alcohol dependency
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Investigated drugs

  • Opioids

    These are strong pain-relieving medications given intravenously (through a vein) to manage pain in patients who need deep sedation in intensive care. They help control pain responses during medical procedures and intensive care treatment.

  • Neuromuscular relaxants

    These medications help relax the muscles completely. They are used alongside sedation to help patients who need deep sedation in intensive care, particularly when they need breathing support from a ventilator.

  • Inhaled sedatives

    These are medications that are given through breathing to make patients unconscious and keep them in a state of deep sleep. They are used to maintain sedation during intensive care treatment.

  • Intravenous sedatives

    These are medications given directly into a vein to maintain a state of deep sleep and unconsciousness. They are an alternative to inhaled sedatives for keeping patients sedated during intensive care treatment.

What is already known about the treatment

  • Opioids

    A class of powerful pain-relieving medications administered intravenously in intensive care settings for patients requiring deep sedation. These medications work by binding to specific opioid receptors in the nervous system, effectively reducing pain perception and providing sedation. Opioids are widely documented in medical literature as standard treatment for severe pain management and sedation in critical care, though their use requires careful monitoring due to potential side effects and dependency risks. They belong to the pharmacological class of central nervous system depressants and are typically used alongside other sedative medications for patients requiring mechanical ventilation or deep sedation in intensive care units.

  • Neuromuscular Relaxants

    Medications administered intravenously to cause temporary muscle paralysis, commonly used in intensive care settings alongside sedatives. These agents work by blocking the communication between nerves and muscles at the neuromuscular junction, resulting in muscle relaxation and improved conditions for mechanical ventilation. They are well-established in medical practice for facilitating intubation and maintaining patient-ventilator synchrony in critically ill patients, belonging to the pharmacological class of peripheral muscle relaxants.

Investigated diseases

  • Critical Illness Delirium

    A serious condition that can develop in critically ill patients, particularly those in intensive care units. It causes sudden changes in mental state, including confusion, disorientation, and altered consciousness. The condition can fluctuate throughout the day, with symptoms often worsening at night. Patients may experience hallucinations, have difficulty focusing attention, and show changes in sleep-wake cycles.

  • Neuromuscular Dysfunction in Critical Illness

    A condition affecting critically ill patients where muscle weakness and nerve problems develop during their illness. The condition causes general muscle weakness throughout the body, particularly affecting the breathing muscles and limbs. It typically develops while patients are in intensive care, especially in those requiring mechanical ventilation or prolonged bed rest.

  • Critical Illness Polyneuropathy

    A neurological disorder that develops in critically ill patients, causing weakness and sensory problems in multiple nerves throughout the body. The condition primarily affects the peripheral nerves, leading to muscle weakness in the limbs and breathing muscles. Symptoms typically develop gradually during the course of critical illness.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521527-74-00Protocol codeEstudio SENOPI-UCIEstimated enrolment144 patientsSponsorHospital Universitari De Girona Doctor Josep Trueta

sourced from the EU Clinical Trials Register and site verification

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