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Opioid-Free Anesthesia in Cardiac Surgery
NCT04940689Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2021
- Primary completion
- Aug 2024
- Countries
- 1
- Sponsor
- Rouen University Hospital
- Modality
- Small Molecules
- Conditions
- Anesthesia
01
Overview
Phase 3, randomised trial of dexmedetomidine and lidocaine in Anesthesia (2 arms), sponsored by Rouen University Hospital. Primary endpoint: Incidence of major postoperative complications related to opioids at 48 hours. Started Jul 2021; status: completed.
02
Design
2 arms- Study design
- Randomized
Standard arm
General anesthesia strategy with morphine and remifentanil.
OFA arm
General anesthesia strategy without morphine, using dexmedetomidine and lidocaine.
03
Endpoints
Primary
Incidence of major postoperative complications related to opioids
Secondary
Incidence of postoperative nausea and vomiting
Incidence of postsurgery pain
Incidence of atrial rhythm disturbances and / or ventricular postsurgery shock states
Incidence of acute post-surgery renal failure
Incidence of post-surgery adrenal insufficiency
Length of ICU and hospital stay
Incidence of postoperative mortality
Persistence of chronic pain
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