At a glance
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Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery
In Brief
A Phase 3 clinical trial evaluating Esketamine and Normal saline for Depressive Symptoms and 3 related conditions. Completed, enrolled 435 participants across 1 site.
Detailed Summary
Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.
Study Details
Timeline
Interventions
Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
Equivalent amount of normal saline will be administrated intravenously suturing incision.