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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,132
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.
Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring
Chu D'Amiens Picardie
Amiens, France
NOT_YET_RECRUITINGChru de Besancon
Besançon, France
NOT_YET_RECRUITINGChu Clermont-Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGChu de Grenoble
Grenoble, France
NOT_YET_RECRUITINGChu de Lille
Lille, France
NOT_YET_RECRUITINGAPHM - Centre Hôpital Marseille Nord
Marseille, France
NOT_YET_RECRUITINGChu de Nantes
Nantes, France
NOT_YET_RECRUITINGChu de Nimes
Nîmes, France
NOT_YET_RECRUITINGHopital Bichat Claude Bernard
Paris, France
NOT_YET_RECRUITINGChu Lyon Sud
Pierre-Bénite, France
NOT_YET_RECRUITING...and 4 more locations
death
Time frame: Day 30
Postoperative acute kidney injury (PO-AKI)
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
Time frame: Day 30
cardiovascular complication
postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation
Time frame: Day 30
neurological complication
Stroke or transient ischemic attack
Time frame: Day 30
Post-operative delirium (POD)
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.
Time frame: Day 30
doses of hypnotics administered
Time frame: during surgery
doses opioids administered;
Time frame: during surgery
number and duration of hypotensive periods
an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.
Time frame: during surgery
time spent within the desired range of sedation:
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 AND Suppression Ratio (SR) at 0 or Entropy Sensor™: State entropy (SE) between 45 and 60 AND Burst Suppression Ratio (BSR) at 0 The anesthetist will have access to the value of sedation monitoring in the "intervention" group; these data will be recorded but not available to the anesthetist in the "control" group: they will be analyzed at the end of the study to answer this point.
Time frame: during surgery
time spent within the desired range of analgesia:
Nociception monitor PMD-200® : Nociception Level (NOL) between 10 and 25. The anesthetist will have access to the value of sedation and analgesia monitoring in the "intervention" group; these data will be recorded but not available to the anesthetist in the "control" group: they will be analyzed at the end of the study to answer this point.
Time frame: during surgery
doses of vasopressive amines (ephedrine or norepinephrine) administered;
Time frame: during surgery
pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)
VAS 0 to 10 \[0 corresponds to no pain - 10 corresponds to maximum pain\]
Time frame: At 48 Hours after surgery
dose of opioid administered;
Time frame: At 48 Hours after surgery
incidence of awareness and recall during anesthesia (explicit memory).
Time frame: At 48 Hours after surgery
acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)
Time frame: Day 30
duration of stay in Intensive Care Unit (ICU);
Time frame: Day 30
rate of unexpected ICU admission, or readmission
Time frame: Day 30
duration of hospital stay;
Time frame: Day 30
early hospital readmission rate
Time frame: Day 30
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