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

Anshi Wu

Status: Unknown

Conditions: Postoperative Depression

Treatments: Drug: Esketamine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05155969

10110815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Eskatamine group

Experimental group

Description:

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

Treatment:

Drug: Esketamine

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline