Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nol index.
- Who it may be relevant to
- Registry conditions: Anesthesia, Intensive Care Medicine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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?
Interventions
- Procedure Nol index
Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.
Primary outcome measures
- Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus. [Time frame: From enrollment to within 48 hours post-extubation.]
Secondary outcome measures (12)
- Total consumption of intraoperative morphinomimetics [Time frame: From intervention to 48 hours after extubation]
- Total consumption of intraoperative vasoconstrictors [Time frame: From induction to extubation, up to 8 hours]
- Time of extubation [Time frame: 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 [Time frame: From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours]
- Maximum intensity of pain [Time frame: From extubation to 48 hours postoperative]
- Number of episodes of pain [Time frame: From extubation to 48 hours postoperative.]
- Number of episodes of hypoxemia [Time frame: From intervention to 48 hours post-extubation]
- Number of episodes of nausea and vomiting [Time frame: From intervention to 48 hours post-extubation]
- Hospital stay length [Time frame: From admission to hospital discharge up to 1 month.]
- Quality of post-operative recovery [Time frame: From enrollment to 24 hours and 48 hours after chirurgical intervention]
- Intensity of chronic pain [Time frame: At 3 months, at 6 months and at 12 months (end of the study)]
- Occurrence of hypoxemia [Time frame: From enrollment to 48 hours post-extubation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 6 centers
- Chu Angers — Angers
- CH BLOIS — Blois
- Chu Brest — Brest
- Chu Nantes — Nantes
- Chru Tours Sar1 — Tours
- Chru Tours Sar2 — Tours
Identifiers
NCT: NCT06861634 · DR220248