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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Depression
• Intervention / Treatment: Drug: Esketamine; Drug: Normal saline

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anshi Wu Wu, Ph.D; Phone Number: Wu +861085351330; Email: wuanshi1965@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chaoyang Hospital, Capital Medical University
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chaoyang Hospital
      • Contact: Anshi Wu, Ph.D; Phone Number: Wu anshi +861085351330; Email: wuanshi1965@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.
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
Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS)	Postoperative complications	Postoperative 5 days
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	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

Collaborators and Investigators

• Sponsor: Anshi Wu
• Investigators: Study Chair: Anshi Wu Wu, Ph.D, Beijing Chao-Yang Hospital, Capital Medical Unive

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 5, 2021
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: esketamine; postoperative depression; cardic surgey
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Psychotropic Drugs; Antidepressive Agents; Ketamine; Esketamine
• Other Study ID Numbers: 10110815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No