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

Anshi Wu80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Depression

Interventions

EsketamineDRUG

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

Normal salineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Postoperative 5 Days

Secondary Outcomes

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.

Time frame: Postoperative 5 days

Postoperative delirium

Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: postoperative 30 days

Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)

Central Contacts

Anshi Wu Wu, Ph.D

CONTACT

+861085351330 wuanshi1965@163.com

Data from ClinicalTrials.gov

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