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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eskatamine group | Experimental | Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction |
|
| Placebo group | Placebo Comparator | Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ≥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 | Postoperative 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety symptom | 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. | Postoperative 5 days |
| Postoperative delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anshi Wu Wu, Ph.D | Contact | +861085351330 | Wu | wuanshi1965@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Anshi Wu Wu, Ph.D | Beijing Chao-Yang Hospital, Capital Medical Unive | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Normal saline | Drug | 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. |
|
|
Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU)
| 1-7days after surgery, on the 30th day after surgery |
| Postoperative insomnia | 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 5 days |
| Severe pain | 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 3 days. |
| Postoperative 30-day quality of life reported by SF-36 | 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. | postoperative 30 days |
| Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS) | Postoperative complications | Postoperative 5 days |
| 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 | 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 2 days |
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |