Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk (OPTI-TWO)

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Sedation and Analgesia Monitoring

Treatments

Procedure: anesthesia performed according only to the clinical judgment of the anesthetist as usual practice

Procedure: anesthesia guided by sedation and analgesia monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT05893030

20PH283

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,132 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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;