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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,132
- 试验地点
- 31
- 主要终点
- neurological complication
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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.
排除标准
- 未提供
研究组 & 干预措施
Control Group
干预措施: anesthesia performed according only to the clinical judgment of the anesthetist as usual practice (Procedure)
Intervention Group
干预措施: anesthesia guided by sedation and analgesia monitoring (Procedure)
结局指标
主要结局
neurological complication
时间窗: Day 30
Stroke or transient ischemic attack
death
时间窗: Day 30
Post-operative delirium (POD)
时间窗: Day 30
Post-operative delirium (POD) will be evaluated using the 3-minute Diagnostic Confusion Assessment Method (3D-CAM), appropriated and validated for the assessment of delirium in the postoperative period, or the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for the intubated patients.
Postoperative acute kidney injury (PO-AKI)
时间窗: Day 30
The PO-AKI will be defined as an increase to 1.5 times the reference level, or as more than 0.3 mg.dl-1 (i.e. 26.5 µmol.l-1) between the last preoperative value and the maximal value observed after surgery, or urine volume \< 0.5 ml.kg-1.h-1 for 6 hours, according to the recommendations of the Acute Kidney Injury Network
cardiovascular complication
时间窗: Day 30
postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation
次要结局
- pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)(At 48 Hours after surgery)
- doses opioids administered;(during surgery)
- time spent within the desired range of sedation:(during surgery)
- time spent within the desired range of analgesia:(during surgery)
- doses of vasopressive amines (ephedrine or norepinephrine) administered;(during surgery)
- incidence of awareness and recall during anesthesia (explicit memory).(At 48 Hours after surgery)
- rate of unexpected ICU admission, or readmission(Day 30)
- doses of hypnotics administered(during surgery)
- duration of hospital stay;(Day 30)
- early hospital readmission rate(Day 30)
- dose of opioid administered;(At 48 Hours after surgery)
- duration of stay in Intensive Care Unit (ICU);(Day 30)
- number and duration of hypotensive periods(during surgery)
- acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)(Day 30)