Clinical trial NCT05893030: Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedation and Analgesia Monitoring
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2023-06-07
Enrollment: 1132
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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;

Primary outcomes:
measure: death
timeFrame: Day 30
measure: Postoperative acute kidney injury (PO-AKI)
timeFrame: Day 30
measure: cardiovascular complication
timeFrame: Day 30
measure: neurological complication
timeFrame: Day 30
measure: Post-operative delirium (POD)
timeFrame: Day 30
Secondary outcomes:
measure: doses of hypnotics administered
timeFrame: during surgery
measure: doses opioids administered;
timeFrame: during surgery
measure: number and duration of hypotensive periods
timeFrame: during surgery
measure: time spent within the desired range of sedation:
timeFrame: during surgery
measure: time spent within the desired range of analgesia:
timeFrame: during surgery
measure: doses of vasopressive amines (ephedrine or norepinephrine) administered;
timeFrame: during surgery
measure: pain ≥ 5 as assessed with the Visual Analogic Scale (VAS)
timeFrame: At 48 Hours after surgery
measure: dose of opioid administered;
timeFrame: At 48 Hours after surgery
measure: incidence of awareness and recall during anesthesia (explicit memory).
timeFrame: At 48 Hours after surgery
measure: acute respiratory failure or Acute Respiratory Distress Syndrome (ARDS)
timeFrame: Day 30
measure: duration of stay in Intensive Care Unit (ICU);
timeFrame: Day 30
measure: rate of unexpected ICU admission, or readmission
timeFrame: Day 30
measure: duration of hospital stay;
timeFrame: Day 30
measure: early hospital readmission rate
timeFrame: Day 30
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu D'Amiens Picardie
city: Besançon
country: France
facility: Chru de Besancon
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Grenoble
country: France
facility: Chu de Grenoble
city: Lille
country: France
facility: Chu de Lille
city: Marseille
country: France
facility: APHM - Centre Hôpital Marseille Nord
city: Nantes
country: France
facility: Chu de Nantes
city: Nîmes
country: France
facility: Chu de Nimes
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Pierre-Bénite
country: France
facility: Chu Lyon Sud
city: Poitiers
country: France
facility: Chu de Poitiers
city: Saint-Étienne
country: France
facility: Chu St-Etienne
city: Toulouse
country: France
facility: Chu de Toulouse
city: Villeurbanne
country: France
facility: Médipole Lyon Villeurbanne
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: David CHARIER, MD
role: PRINCIPAL_INVESTIGATOR
References: