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.
patients affiliated to the French Social Security;
informed and signed consent to participating in the study;
planned postoperative hospitalization > 48 hours;
ischemic coronary disease;
None
Parallel
anesthesia guided by sedation and analgesia monitoring
Procedure/SurgeryAnesthesia 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.
anesthesia performed according only to the clinical judgment of the anesthetist as usual practice
Procedure/SurgeryAdministration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring
death
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
cardiovascular complication
postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation
neurological complication
Stroke or transient ischemic attack
doses of hypnotics administered
doses opioids administered;
number and duration of hypotensive periods
an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.
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.
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Centre Hospitalier Universitaire de Saint Etienne
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
