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

Regional University Hospital Center (CHRU)

Status

Not yet enrolling

Conditions

Intensive Care Medicine

Anesthesia

Treatments

Procedure: Nol index

Study type

Interventional

Funder types

Other

Identifiers

NCT06861634

DR220248

Details and patient eligibility

About

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?

Enrollment

332 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.