Postoperative Depression
Conditions
Keywords
esketamine, postoperative depression, cardic surgey
Brief summary
Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients.
Detailed description
Single subanaesthetic doses of i.v. esketamine may significantly improve symptoms in psychiatric patients with major depression. In patients undergoing cardiac surgery, postoperative depressive symptoms are common. This study hypothesizes that low-dose esketamine has a preventive effect on postoperative depression. However, evidence in this aspect is insufficient. The purpose of this study is to investigate the effect of a subanaesthetic dose of ketamine on POD for patients undergoing cardiac surgery.
Interventions
DRUGEsketamine
esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction
DRUGNormal saline
Normal saline will be administrated intravenously at the dural opening, with a total dose of 0.5 ml/kg and continual infusion for 40 minutes.
Sponsors
Anshi Wu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1:Patients scheduled for heart surgery * 2:Moderate to severe depressive symptom measured by the qualified psychiatric doctors * 3:Over 18 years of age * 4:American Society of Anesthesiologists physical status I-III
Exclusion criteria
* 1:History of epilepsy * 2:Major depression disorder patients undergoing antidepressive therapy within 2 weeks * 3: Psychiatric illness * 4: Drug abuse * 5:History of allergy to esketamine * 6:Hyperthyroidism * 7:Patients can not cooperate with investigators on psychiatric assessments * 8:Pregnant or breastfeeding woman * 9:refuse to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Postoperative 5 Days | ≥50% reduction in MADRS scores from the baseline value. The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | 1-7days after surgery, on the 30th day after surgery | Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU) |
| Severe pain | Postoperative 3 days. | The incidence of severe pain within first postoperative three days, which is defined as mean and peak numerical rating scale (NRS) are higher than 5. |
| Postoperative insomnia | Postoperative 5 days | Postoperative insomnia is defined as an ISI score of no less than 15. ISI is a 7-item tool, with scores ranging from 0 to 28, The higher the score, the worse insomnia. |
| Postoperative 30-day quality of life reported by SF-36 | postoperative 30 days | The quality of life will be evaluated by the 36-Item Short-Form Health Survey, SF-36 at postoperative 30 days SF-36 is a 36-item tool, with scores ranging from 1 to 100, The higher the score, the better the quality of life. |
| Anxiety symptom | Postoperative 5 days | The anxious symptom is defined as a GAD-7 score no less than 10. The GAD-7 is a 7-item tool, with scores ranging from 0 to 21, The higher the score, the worse the anxiety. |
| Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS) | Postoperative 5 days | — |
| Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS). | Postoperative 5 days | — |
| Postoperative pain | Postoperative 2 days | The postoperative pain will be evaluated by Numerical pain scale（NRS） NRS is a tool with scores ranging from 1 to 10, the higher the score, the more intense the pain |
| Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS) | Postoperative 5 days | Postoperative complications |
Countries
China
Contacts
Primary ContactAnshi Wu Wu, Ph.D
Outcome results
None listed