drugset / Trial / NCT04886453

Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

NCT04886453

Phase 3 Completed 321 enrolled Centre Hospitalier Universitaire Dijon
RandomizedParallel-groupSingle-blindTreatment

Summary

Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function: * better analgesia and decreased postoperative morphine consumption, * better respiratory function, * better hemodynamic stability, * better postoperative cognitive function. The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with: * Improved intraoperative hemodynamic stability * A decrease in the incidence of postoperative complications * A reduction in intensive care and hospital length of stay

Timeline

Start
2021-08-30
Primary completion
2024-03-21
Completion
2024-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule Intravenous
Subject Ketamine Small molecule Intravenous
Subject Lidocaine Other / unclassified Intravenous
Subject Magnesium Sulfate Other / unclassified Intravenous
Comparator Morphine Other / unclassified

Indications

No indication recorded.