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

Postoperative Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155969
• Other study ID #: 10110815
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: December 2021
• Source: Beijing Chao Yang Hospital
• Contact: Anshi Wu Wu, Ph.D
• Phone: +861085351330
• Email: wuanshi1965[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 15, 2022
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Postoperative Depression

Intervention

Drug:
• Esketamine
esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction
• Normal 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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Anshi Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)	Postoperative complications	Postoperative 5 days
Secondary	Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)		Postoperative 5 days
Secondary	Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).		Postoperative 5 days
Secondary	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