Clinical trial NCT06861634: Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics
Official title: Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Intensive Care Medicine
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

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?


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Treatment with β-blockers
* Preoperative cardiac arrhythmia
* Pregnant or breast-feeding women. A β-HCG test will be systematically performed prior to inclusion of non-menopausal women menopausal women
* Patients under legal protection (safeguard of justice, curatorship guardianship) or deprived of liberty
* Participation in other interventional research involving an experimental drug or medical device.

Primary outcomes:
measure: Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.
timeFrame: From enrollment to within 48 hours post-extubation.
Secondary outcomes:
measure: Total consumption of intraoperative morphinomimetics
timeFrame: From intervention to 48 hours after extubation
measure: Total consumption of intraoperative vasoconstrictors
timeFrame: From induction to extubation, up to 8 hours
measure: Time of extubation
timeFrame: From the end of anesthesia administration to extubation, up to 1 hours
measure: Time from extubation to theoretical post-anesthesia care unit discharge time with Aldrete score at 10
timeFrame: From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours
measure: Maximum intensity of pain
timeFrame: From extubation to 48 hours postoperative
measure: Number of episodes of pain
timeFrame: From extubation to 48 hours postoperative.
measure: Number of episodes of hypoxemia
timeFrame: From intervention to 48 hours post-extubation
measure: Number of episodes of nausea and vomiting
timeFrame: From intervention to 48 hours post-extubation
measure: Hospital stay length
timeFrame: From admission to hospital discharge up to 1 month.
measure: Quality of post-operative recovery
timeFrame: From enrollment to 24 hours and 48 hours after chirurgical intervention
measure: Intensity of chronic pain
timeFrame: At 3 months, at 6 months and at 12 months (end of the study)
measure: Occurrence of hypoxemia
timeFrame: From enrollment to 48 hours post-extubation
measure: Occurrence of nausea-vomiting
timeFrame: From enrollment to 48 hours post-extubation
measure: Occurrence of ileus
timeFrame: From enrollment to 48 hours post-extubation
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Blois
country: France
facility: CH BLOIS
city: Brest
country: France
facility: Chu Brest
city: Nantes
country: France
facility: Chu Nantes
city: Tours
country: France
facility: Chru Tours Sar1
city: Tours
country: France
facility: Chru Tours Sar2
Study officials:
References: