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

Not Applicable

• Conditions: Postoperative Depression
• Interventions: Drug: Normal saline; Drug: Esketamine

• Registration Number: NCT05155969
• Lead Sponsor: Anshi Wu

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.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Primary Completion: 2021-12-05
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-13
• Last Update Submitted: 2021-12-13
• Study First Posted: 2021-12-14
• Last Update Posted: 2021-12-14
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Normal saline	Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.
Eskatamine group	Esketamine	Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
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.
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 complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)	Postoperative 5 days	Postoperative complications
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

Trial Locations

Locations (2)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China