Status:

COMPLETED

Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery

Lead Sponsor:

Chinese PLA General Hospital

Collaborating Sponsors:

Beijing Tiantan Hospital

The Sixth Medical Center of Chinese PLA General Hospital

Conditions:

Depression, Anxiety

Cardiac Surgery

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

A multicenter, randomized controlled, blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.

Detailed Description

Undergoing surgery can be a traumatic and painful experience for patients, often causing negative moods such as anxiety and depression. The size and type of surgery significantly impact the occurrence...

Eligibility Criteria

Inclusion

  • Age ≥18 years old, male or female
  • Patients undergoing heart valve surgery
  • Patients with ASA grade 1 to 4
  • BMI between 18-30 kg/m²
  • Able to participate in neuropsychological testing and receive follow-up visits
  • Clearly understand and voluntarily agree to participate in the study and sign the informed consent form

Exclusion

  • Patients with significant preoperative neuro-psychiatric disease and cognitive impairment
  • Intellectual disability or a MiniMental State Examination (MMSE) score \<24, or a speech disorder that may compromise their ability to undergo preoperative assessments
  • History of psychoactive drug abuse
  • 5\. Preoperative combined severe hepatic insufficiency or renal insufficiency 6. Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism

Key Trial Info

Start Date :

September 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 30 2025

Estimated Enrollment :

142 Patients enrolled

Trial Details

Trial ID

NCT06608030

Start Date

September 23 2024

End Date

April 30 2025

Last Update

November 25 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

First Medical center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China, China

2

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China