Clinical trial NCT05155969: Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Depression
Keywords: esketamine
postoperative depression
cardic surgey
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response rate
timeFrame: Postoperative 5 Days
Secondary outcomes:
measure: Anxiety symptom
timeFrame: Postoperative 5 days
measure: Postoperative delirium
timeFrame: 1-7days after surgery, on the 30th day after surgery
measure: Postoperative insomnia
timeFrame: Postoperative 5 days
measure: Severe pain
timeFrame: Postoperative 3 days.
measure: Postoperative 30-day quality of life reported by SF-36
timeFrame: postoperative 30 days
measure: Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)
timeFrame: Postoperative 5 days
measure: Psychiatric manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS)
timeFrame: Postoperative 5 days
measure: Psychiatric dissociative symptoms measured by the Clinician-Administered Dissociative States Scale (CADSS).
timeFrame: Postoperative 5 days
measure: Postoperative pain
timeFrame: Postoperative 2 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao-Yang Hospital, Capital Medical Unive
name: Anshi Wu Wu, Ph.D
role: STUDY_CHAIR
References: