Evaluation of Opioid Consumption Using Objective Nociceptive Monitoring in Patients Indicated for Deep Sedation in the Intensive Care Unit

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitari De Girona Doctor Josep Trueta

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-07-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

- 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.

Secondary objectives 4

1. Record the required doses of intravenous opioids for each patient, both monitored and unmonitored with NOL, over a 72-hour period while they are under deep sedation and muscle relaxation.
2. Record episodes of withdrawal upon opioid discontinuation.
3. Record other adverse effects resulting from opioid use.
4. Evaluate the application of multimodal analgesia and adjuvants, recording their dosage and duration

Conditions and MedDRA coding

NEUROCRITIC PATIENTS

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients of both sexes aged ≥ 18 years
2. Indication for deep sedation (RASS < -4)
3. 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
4. Expected ICU stay of at least 72 hours.
5. Signed informed consent from the patient, family member, or legal representative.

Exclusion criteria 3

1. End-of-life situation or poor vital prognosis
2. Physical impossibility of monitoring with NOL.
3. Contraindications to NOL or sedation with isoflurane

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Sedation variables:Respiratory, hemodynamic, neuromonitoring, and infectious status variables.

Secondary endpoints 1

1. Observed Adverse Effects Throughout the Study:- Time to awakening and presence/absence of delirium during the patient's awakening process. - ICU length of stay. - Hospital length of stay. - ICU mortality. - Hospital mortality- Opiodis abstincence

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitari De Girona Doctor Josep Trueta

Sponsor organisation

Hospital Universitari De Girona Doctor Josep Trueta

Address

Avinguda De Franca S/n

City

Girona

Postcode

17007

Country

Spain

Scientific contact point

Organisation

Hospital Universitari De Girona Doctor Josep Trueta

Contact name

Marina Vila

Public contact point

Organisation

Hospital Universitari De Girona Doctor Josep Trueta

Contact name

Marina Vila

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications