Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk

Официальное название

Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk: the Opti-Two Study. A Multi-center Controlled Randomized Study.

Обзор

Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery. Intraoperative hypotension is partly related to anesthesia, and mainly to the combined, dose-dependent, synergistic effect of hypnotics and opioids. Monitoring sedation and monitoring analgesia reduce intraoperative consumption of each anesthetic agent. To date, the beneficial effect of combined sedation and analgesia monitoring on the reduction of intraoperative hypotension has only been found in one study, involving major abdominal surgery. Up to now, no study has been designed to demonstrate the benefit of monitoring the two components of anesthesia on postoperative organ dysfunction and mortality. The study propose to evaluate the relevance of a combined optimization of hypnotic and opioid agents on the most frequently encountered dysfunctions related to intraoperative hypotension.

Вмешательства

• Процедура anesthesia guided by sedation and analgesia monitoring
  Anesthesia guided by sedation and analgesia monitoring The level of sedation will be monitored by * Monitoring System BIS™ : Bispectral index (BIS) between 45 and 60 AND Suppression Ratio (SR) at 0; * or SedLine® Sedation Monitor : Patient State Index (PSi) between 25 and 50; * or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0; and the level of nociception by : * Nociception monitor PMD-200® : Nociception Level (NoL) between 10 and 25.
• Процедура anesthesia performed according only to the clinical judgment of the anesthetist as usual practice
  Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring

Первичные конечные точки

• death [Срок оценки: Day 30]
• Postoperative acute kidney injury (PO-AKI) [Срок оценки: Day 30]
• cardiovascular complication [Срок оценки: Day 30]
• neurological complication [Срок оценки: Day 30]
• Post-operative delirium (POD) [Срок оценки: Day 30]

Вторичные конечные точки (12)

• doses of hypnotics administered [Срок оценки: during surgery]
• doses opioids administered; [Срок оценки: during surgery]
• number and duration of hypotensive periods [Срок оценки: during surgery]
• time spent within the desired range of sedation: [Срок оценки: during surgery]
• time spent within the desired range of analgesia: [Срок оценки: during surgery]
• doses of vasopressive amines (ephedrine or norepinephrine) administered; [Срок оценки: during surgery]
• pain ≥ 5 as assessed with the Visual Analogic Scale (VAS) [Срок оценки: At 48 Hours after surgery]
• dose of opioid administered; [Срок оценки: At 48 Hours after surgery]
• incidence of awareness and recall during anesthesia (explicit memory). [Срок оценки: At 48 Hours after surgery]
• acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS) [Срок оценки: Day 30]
• duration of stay in Intensive Care Unit (ICU); [Срок оценки: Day 30]
• rate of unexpected ICU admission, or readmission [Срок оценки: Day 30]

Критерии участия

Критерии включения

• patients affiliated to the French Social Security;
• informed and signed consent to participating in the study;
• planned postoperative hospitalization > 48 hours;
• patients over 75 years of age with at least one of the following postoperative risk factors:

• ischemic coronary disease;
• history of compensated or prior heart failure;
• stroke;
• significant arrhythmias: fibrillation or auricular flutter with ventricular response > 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree);
• peripheral vascular disease;
• chronic obstructive pulmonary disease;
• chronic respiratory failure;
• renal insufficiency, defined by a creatinine > 175 µmol.l-1 (2 mg.dl-1);
• insulin therapy for diabetes;
• active cancer;
• chronic alcohol abuse;
• dementia.
• elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device

Non inclusion criteria:

• Patients who meet one or more of the preoperative following criteria will not be included:
• acute heart failure or acute myocardial infarction;
• complete arrhythmia due to atrial fibrillation;
• acute respiratory failure or pneumonia;
• septic shock;
• acute stroke;
• cardiac surgery;
• open chest surgery;
• opioid free anesthesia;
• intraoperative ketamine at a dose > 0.25 mg.kg-1; > 0.25 mg/kg or or intravenous electric syringe
• lidocaine or dexmedetomidine by continuous infusion;
• refusal to participate in the study;
• patient under guardianship, conservatorship, or unable to understand the study.

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

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 18 центров

• Chu D'Amiens Picardie — Amiens
• Clinique Victor Pauchet — Amiens
• Chru de Besancon — Besançon
• Polyclinique Bordeaux Nord Aquitaine — Bordeaux
• Chu Clermont-Ferrand — Clermont-Ferrand
• Chu de Grenoble — Grenoble
• Chu de Lille — Lille
• APHM - Centre Hôpital Marseille Nord — Marseille
• … и ещё 10 центров

Идентификаторы

NCT: NCT05893030 · 20PH283 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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