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

Not Applicable

Recruiting

• Conditions: Sedation and Analgesia Monitoring
• Interventions: Procedure: anesthesia performed according only to the clinical judgment of the anesthetist as usual practice; Procedure: anesthesia guided by sedation and analgesia monitoring

• Registration Number: NCT05893030
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-07
• Study Start: 2023-10-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15
• Primary Completion: 2027-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1132

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:

  • 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;
• acute respiratory failure or pneumonia;
• septic shock;
• acute stroke;
• cardiac surgery;
• open chest surgery;
• opioid free anesthesia;
• intraoperative ketamine at a dose > 0.2 mg.kg-1;
• lidocaine or dexmedetomidine by continuous infusion;
• refusal to participate in the study;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	anesthesia performed according only to the clinical judgment of the anesthetist as usual practice	-
Intervention Group	anesthesia guided by sedation and analgesia monitoring	-

Primary Outcome Measures

Name	Time	Method
death	Day 30
cardiovascular complication	Day 30	postoperative myocardial infarction, acute heart failure, acute/non pre-existing atrial fibrillation or flutter, cardiac arrest with successful resuscitation, coronary revascularisation
neurological complication	Day 30	Stroke or transient ischemic attack
Post-operative delirium (POD)	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)	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

Secondary Outcome Measures

Name	Time	Method
pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)	At 48 Hours after surgery	VAS 0 to 10 \[0 corresponds to no pain - 10 corresponds to maximum pain\]
doses opioids administered;	during surgery
time spent within the desired range of sedation:	during surgery	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 spent within the desired range of analgesia:	during surgery	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.
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
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
doses of hypnotics administered	during surgery
number and duration of hypotensive periods	during surgery	an hypotensive event will be defined as a Mean Arterial Pressure (MAP) ≤ 65 mmHg.
acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)	Day 30

Trial Locations

Locations (14)

Chu D'Amiens Picardie; 🇫🇷 Amiens, France

Chu de Nantes; 🇫🇷 Nantes, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

APHM - Centre Hôpital Marseille Nord; 🇫🇷 Marseille, France

Chru de Besancon; 🇫🇷 Besançon, France

Chu de Grenoble; 🇫🇷 Grenoble, France

Chu de Lille; 🇫🇷 Lille, France

Chu de Nimes; 🇫🇷 Nîmes, France

Chu Lyon Sud; 🇫🇷 Pierre-Bénite, France

Hopital Bichat Claude Bernard; 🇫🇷 Paris, France

Chu de Poitiers; 🇫🇷 Poitiers, France

Chu St-Etienne; 🇫🇷 Saint-Étienne, France

Médipole Lyon Villeurbanne; 🇫🇷 Villeurbanne, France

Chu de Toulouse; 🇫🇷 Toulouse, France