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

Официальное название

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

Обзор

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?

Вмешательства

• Процедура Nol index
  Morphinomimetics will be administered according to NOL Index values or according to the usual criteria.

Первичные конечные точки

• Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus. [Срок оценки: From enrollment to within 48 hours post-extubation.]

Вторичные конечные точки (12)

• Total consumption of intraoperative morphinomimetics [Срок оценки: From intervention to 48 hours after extubation]
• Total consumption of intraoperative vasoconstrictors [Срок оценки: From induction to extubation, up to 8 hours]
• Time of extubation [Срок оценки: 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 [Срок оценки: From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours]
• Maximum intensity of pain [Срок оценки: From extubation to 48 hours postoperative]
• Number of episodes of pain [Срок оценки: From extubation to 48 hours postoperative.]
• Number of episodes of hypoxemia [Срок оценки: From intervention to 48 hours post-extubation]
• Number of episodes of nausea and vomiting [Срок оценки: From intervention to 48 hours post-extubation]
• Hospital stay length [Срок оценки: From admission to hospital discharge up to 1 month.]
• Quality of post-operative recovery [Срок оценки: From enrollment to 24 hours and 48 hours after chirurgical intervention]
• Intensity of chronic pain [Срок оценки: At 3 months, at 6 months and at 12 months (end of the study)]
• Occurrence of hypoxemia [Срок оценки: From enrollment to 48 hours post-extubation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 6 центров

• Chu Angers — Angers
• CH BLOIS — Blois
• Chu Brest — Brest
• Chu Nantes — Nantes
• Chru Tours Sar1 — Tours
• Chru Tours Sar2 — Tours

Идентификаторы

NCT: NCT06861634 · DR220248

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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