Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics
NCT ID: NCT06861634
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
332 participants
INTERVENTIONAL
2025-03-31
2028-04-30
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Group NOL
Morphinomimetics will be administered according to NOL Index values.
Nol index
Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.
Group control
Morphinomimetics will be administered according to the usual criteria.
No interventions assigned to this group
Interventions
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Nol index
Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Locations
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Chu Angers
Angers, , France
CH BLOIS
Blois, , France
Chu Brest
Brest, , France
Chu Nantes
Nantes, , France
Chru Tours Sar1
Tours, , France
Chru Tours Sar2
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DR220248
Identifier Type: -
Identifier Source: org_study_id
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