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

Sponsor

Anshi Wu (Other)

Overall Status

Recruiting

CT.gov ID

NCT05155969

Collaborator

(none)

Enrollment

Locations

Arms

12.5

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Depression	Drug: Esketamine Drug: Normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Dec 5, 2021

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eskatamine group Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction	Drug: Esketamine esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction Other Names: Ketamine hydrochloride
Placebo Comparator: Placebo group Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.	Drug: 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. Other Names: saline

Arm

Intervention/Treatment

Experimental: Eskatamine group

Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction

Drug: Esketamine

esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction

Other Names:

Ketamine hydrochloride

Placebo Comparator: Placebo group

Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.

Drug: 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.

Other Names:

saline

Outcome Measures

Primary Outcome Measures

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

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 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 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 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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.