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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
435
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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Depressive symptoms remission
Remission is defined as the Montgomery-Åsberg Depression Rating Scale (MADRS) total score no more than 10, MADRS is a sensitive tool used for tracking improvement or progression in patients with major depressive disorder, consisting of 10 items that jointly assess the degree of depressive symptoms.
Time frame: Postoperative 3-day
MADRS scores
The differences in MADRS scores
Time frame: Postoperative 3-day
Depressive symptoms response
The rates of patients achieving a response
Time frame: Postoperative 3-day
Moderate-to-severe pain
The rate of severe pain after surgery
Time frame: postoperative 3-day
Side-effects and Adverse events
All drug-related adverse events during surgery or before discharge
Time frame: During surgery or up to 7 days after surgery
Long-term patient outcome
The long-term patient outcomes included depressive symptoms and disability as measured by the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at 1, 3, and 6 months after surgery.
Time frame: 1, 3, and 6 months after surgery
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