Esketamine's effects on mood in patients having heart valve surgery
Effect of a Single Dose of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery: a Randomized Controlled Trial
This study is testing if esketamine can help reduce anxiety and depression in patients having heart valve surgery to see if it improves their mood during recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT06608030 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial investigates how esketamine can alleviate anxiety and depression in patients undergoing cardiac valve surgery. The study aims to determine the efficacy of esketamine, a derivative of ketamine known for its analgesic and antidepressant properties, in improving perioperative mood. Participants will receive either esketamine or a placebo (normal saline) and will be monitored for mood changes throughout the surgical process. The trial seeks to address the significant prevalence of negative mood disorders in cardiac surgery patients, which can impact recovery and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for heart valve surgery and meet specific health criteria.
Not a fit: Patients with significant preoperative neuro-psychiatric diseases, cognitive impairments, or contraindications to ketamine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to managing perioperative anxiety and depression, potentially improving recovery outcomes for cardiac surgery patients.
How similar studies have performed: While the use of esketamine for depression is established, this specific application in the perioperative setting is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years old, male or female 2. Patients undergoing heart valve surgery 3. Patients with ASA grade 1 to 4 4. BMI between 18-30 kg/m² 5. Able to participate in neuropsychological testing and receive follow-up visits 6. Clearly understand and voluntarily agree to participate in the study and sign the informed consent form Exclusion Criteria: 1. Patients with significant preoperative neuro-psychiatric disease and cognitive impairment 2. Intellectual disability or a MiniMental State Examination (MMSE) score \<24, or a speech disorder that may compromise their ability to undergo preoperative assessments 3. 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
Where this trial is running
Beijing, Beijing and 1 other locations
- First Medical center of Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
- Beijing Tiantan Hospital — Bejing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Weidong Mi, PhD
- Email: wwdd1962@163.com
- Phone: 13381082966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.