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

NCT05155969 | Unknown DMC

• 1 other identifier: 10110815
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Depression

Keywords

esketamine; postoperative depression; cardic surgey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Anxiety symptom

  Postoperative 5 days

• Postoperative delirium

  1-7days after surgery, on the 30th day after surgery

• Postoperative insomnia

  Postoperative 5 days

• Severe pain

  Postoperative 3 days.

• Postoperative 30-day quality of life reported by SF-36

  postoperative 30 days

Study Arms (2)

Eskatamine group

EXPERIMENTAL

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

Drug: Esketamine

Placebo group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Esketamine DRUG

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

Also known as: Ketamine hydrochloride

Eskatamine group

Normal saline DRUG

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.

Also known as: saline

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• :Patients scheduled for heart surgery
• :Moderate to severe depressive symptom measured by the qualified psychiatric doctors
• :Over 18 years of age
• :American Society of Anesthesiologists physical status I-III

You may not qualify if:

• :History of epilepsy
• :Major depression disorder patients undergoing antidepressive therapy within 2 weeks
• : Psychiatric illness
• : Drug abuse
• :History of allergy to esketamine
• :Hyperthyroidism
• :Patients can not cooperate with investigators on psychiatric assessments
• :Pregnant or breastfeeding woman
• :refuse to sign informed consent.

Sponsors & Collaborators

• Anshi Wu: lead

Study Sites (2)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

Esketamine; Ketamine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anshi Wu Wu, Ph.D

  Beijing Chao-Yang Hospital, Capital Medical Unive

  STUDY CHAIR

Central Study Contacts

Anshi Wu Wu, Ph.D

CONTACT

+861085351330; wuanshi1965@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 14, 2021
• Study Start: December 1, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 15, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

CN (2)