NCT04886453

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Opioid-free Anesthesia
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Balanced general anesthesia without morphine	Balanced general anesthesia without morphine
DRUG	Standard general anesthesia balanced with morphine	Standard general anesthesia balanced with morphine
OTHER	Data collection	Data collection
OTHER	Assessment of pain	visual analog scale
OTHER	Recovery quality score	QoR15 questionnaire

Timeline

• Start date: 2021-08-30
• Primary completion: 2024-03-21
• Completion: 2024-03-21
• First posted: 2021-05-14
• Last updated: 2024-05-17

Locations

1 site across 1 country: France