Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics

NCT06861634 | Not Yet Recruiting

• 1 other identifier: DR220248
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 6

Brief Summary

Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects. However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics. The Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?

Conditions

Anesthesia; Intensive Care Medicine

Outcome Measures

Primary Outcomes (1)

• Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.

  1. occurrence of hypoxemia: at least 1 episode of SpO2 \< 95%, 2. occurrence of nausea-vomiting: at least one episode of nausea requiring antiemetic treatment, or at least one episode of vomiting, 3. occurrence of ileus: absence of gas or stool.

  From enrollment to within 48 hours post-extubation.

Secondary Outcomes (14)

• Total consumption of intraoperative morphinomimetics

  From intervention to 48 hours after extubation

• Total consumption of intraoperative vasoconstrictors

  From induction to extubation, up to 8 hours

• Time of extubation

  From the end of anesthesia administration to extubation, up to 1 hours

• Time from extubation to theoretical post-anesthesia care unit discharge time with Aldrete score at 10

  From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours

• Maximum intensity of pain

  From extubation to 48 hours postoperative

Study Arms (2)

Group NOL

EXPERIMENTAL

Morphinomimetics will be administered according to NOL Index values.

Procedure: Nol index

Group control

NO INTERVENTION

Morphinomimetics will be administered according to the usual criteria.

Interventions

Nol index PROCEDURE

Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.

Group NOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Subject aged ≥ 18 years
• Affiliated with a social security scheme
• Having given written informed consent to participate study
• Admitted for major surgery expected to last more than 2 hours
• Under general anesthesia with tracheal intubation
• For a planned hospital stay of at least 48 hours
• Participant's ability to understand the nature and objectives of the study to comply with study requirements.

You may not qualify if:

• Contraindication to one of the drugs used for anesthesia
• Urgent surgery
• Intracranial surgery
• Transplant surgery
• Cardiac surgery
• Surgery with scheduled local anesthesia
• Patient requiring postoperative intubation
• Neuromuscular disease
• Patient chronically using morphinomimetics
• Chronic pain patient
• Patients with a history of sleep apnea
• Conditions likely to interfere with photoplethysmograph signal acquisition or skin conductance (excessive or tremors of the extremities, skin lesions or burns)
• Patients wearing false nails and/or nail polish
• Contraindication to the use of the PMD 200 ™ medical device (including cardiovascular resuscitation and cardioversion/defibrillation);
• Patient with an implanted pacemaker or defibrillator

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (6)

Chu Angers

Angers, France

Location

CH BLOIS

Blois, France

Location

Chu Brest

Brest, France

Location

Chu Nantes

Nantes, France

Location

Chru Tours Sar1

Tours, France

Location

Chru Tours Sar2

Tours, France

Location

Central Study Contacts

Fabien ESPITALIER, PU-PH

CONTACT

+33 2 47 47 17 47; fabien.espitalier@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)