Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Effect of Subanaesthetic Dose of Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery：a Randomized, Double-blind, Placebo-controlled Pilot and Feasibility Trial

Conditions
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Postoperative Depression

Intervention / Treatment
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* Drug: Esketamine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eskatamine group<br>Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction | Drug: Esketamine<br>* esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction<br>* Other names: Ketamine hydrochloride;|
| Placebo Comparator: Placebo group<br>Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction. | Drug: Normal saline<br>* 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.<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esketamine, postoperative depression, cardic surgey