Depressive Symptoms, Esketamine, Major Surgery, Perioperative Complication
Conditions
Brief 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.
Interventions
DRUGEsketamine
Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
DRUGNormal saline
Equivalent amount of normal saline will be administrated intravenously suturing incision.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient undergoing elective major surgery * Ages between 18 and 65 years old * Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 ) * Signed informed consent
Exclusion criteria
* had aphasia or any conditions that prevented mental health assessments, * had a history of psychotic or bipolar disorder, * had a comorbidity that affected hormone levels, * required prolonged postoperative mechanical ventilation, * had received treatment with antidepressants within 2 weeks prior to the screening, * had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points. * had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3), * had experienced adverse reactions to ketamine or esketamine, * had known drug use disorders, * pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms remission | Postoperative 3-day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS scores | Postoperative 3-day | The differences in MADRS scores |
| Depressive symptoms response | Postoperative 3-day | The rates of patients achieving a response |
| Moderate-to-severe pain | postoperative 3-day | The rate of severe pain after surgery |
| Side-effects and Adverse events | During surgery or up to 7 days after surgery | All drug-related adverse events during surgery or before discharge |
| Long-term patient outcome | 1, 3, and 6 months after surgery | 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. |
Countries
China
Outcome results
None listed