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

1 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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

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
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	05.05.2025

Trial locations

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.

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 ID:

2025-521527-74-00

Protocol code:

Estudio SENOPI-UCI

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?