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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2022-A01122-41 |
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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental |
| |
| Control Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anesthesia guided by sedation and analgesia monitoring | Procedure | Anesthesia guided by sedation and analgesia monitoring The level of sedation will be monitored by
and the level of nociception by :
|
| Measure | Description | Time Frame |
|---|---|---|
| death | 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 | 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 | Day 30 |
| neurological complication | Stroke or transient ischemic attack | 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. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| doses of hypnotics administered | during surgery | |
| doses opioids administered; | during surgery | |
| number and duration of hypotensive periods |
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Inclusion Criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David CHARIER, MD, PhD | Contact | +33.4.77.82.85.65 | david.charier@chu-st-etienne.fr | |
| Marlène BONNEFOI, CRA | Contact | (0)477828822 | +33 | marlene.bonnefoi@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| David CHARIER, MD, PhD | CHU DE SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu D'Amiens Picardie | Recruiting | Amiens | 80054 | France |
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| anesthesia performed according only to the clinical judgment of the anesthetist as usual practice | Procedure | Administration of anesthesia will be performed according to the clinical judgment of the anesthetist as usual practice without sedation and analgesia monitoring |
|
an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg. |
| 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. | 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. | during surgery |
| doses of vasopressive amines (ephedrine or norepinephrine) administered; | 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] | At 48 Hours after surgery |
| dose of opioid administered; | At 48 Hours after surgery |
| incidence of awareness and recall during anesthesia (explicit memory). | At 48 Hours after surgery |
| acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS) | Day 30 |
| duration of stay in Intensive Care Unit (ICU); | Day 30 |
| rate of unexpected ICU admission, or readmission | Day 30 |
| duration of hospital stay; | Day 30 |
| early hospital readmission rate | Day 30 |
| Clinique Victor Pauchet | Recruiting | Amiens | 80090 | France |
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| Chru de Besancon | Not yet recruiting | Besançon | 25030 | France |
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| Polyclinique Bordeaux Nord Aquitaine | Recruiting | Bordeaux | 33300 | France |
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| Chu Clermont-Ferrand | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Chu de Grenoble | Not yet recruiting | Grenoble | 38700 | France |
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| Chu de Lille | Recruiting | Lille | 59037 | France |
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| APHM - Centre Hôpital Marseille Nord | Not yet recruiting | Marseille | 13015 | France |
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| Chu de Nantes | Not yet recruiting | Nantes | 44093 | France |
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| Chu de Nimes | Recruiting | Nîmes | 30000 | France |
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| Hopital Bichat Claude Bernard | Recruiting | Paris | 75018 | France |
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| Chu Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
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| Chu de Poitiers | Recruiting | Poitiers | 86000 | France |
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| Hôpital Saint Charles | Not yet recruiting | Saint-Dié | 88100 | France |
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| Chu St-Etienne | Recruiting | Saint-Etienne | 42100 | France |
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| Chu de Toulouse | Recruiting | Toulouse | 31059 | France |
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| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94800 | France |
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| Médipole Lyon Villeurbanne | Recruiting | Villeurbanne | 69100 | France |
|