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EVALUATION OF OPIOID CONSUMPTION USING OBJECTIVE NOCICEPTIVE MONITORING IN PATIENTS INDICATED FOR DEEP SEDATION IN THE INTENSIVE CARE UNIT
EU CTIS ID: 2025-521527-74-00
What this study is testing
- Evaluate the consumption of intravenous opioids in patients indicated for deep sedation and the use of neuromuscular relaxants with inhaled sedation monitored with NOL versus without objective nociception monitoring. - Evaluate the consumption of intravenous opioids in patients indicated for deep sedation and the use of neuromuscular relaxants with inhaled sedation monitored with NOL versus patients with intravenous sedation and nociception monitoring. - Evaluate the consumption of intravenous opioids in patients indicated for deep sedation and the use of neuromuscular relaxants with intravenous sedation monitored with NOL versus patients with intravenous sedation and without nociception monitoring.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes aged ≥ 18 years
- Indication for deep sedation (RASS < -4)
- Need for neuromuscular relaxation. The use of neuromuscular blocking agents (NMBAs) in deep sedation in the ICU is indicated in situations requiring complete muscle paralysis to optimize mechanical ventilation and reduce oxygen consumption, such as ARDS, increased intracranial pressure (ICP), and status epilepticus. Prolonged use (>72h) should be avoided to prevent ICU-acquired weakness. In our unit, we primarily use cisatracurium (a non-depolarizing NMBA) as a continuous infusion at 1-4 mcg/kg/min and rocuronium (a non-depolarizing NMBA) as a bolus at 0.6-1.2 mg/kg or a continuous infusion at 4-12 mcg/kg/min. We monitor its administration using Train-of-Four (TOF) to prevent overdosing
- Expected ICU stay of at least 72 hours.
- Signed informed consent from the patient, family member, or legal representative.
You likely can't join if
- End-of-life situation or poor vital prognosis
- Physical impossibility of monitoring with NOL.
- Contraindications to NOL or sedation with isoflurane
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.