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Depression, AnxietyNCT06608030

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

A study testing Esketamine and normal saline in people with Depression, Anxiety and Cardiac Surgery, run by Chinese PLA General Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety, Cardiac Surgery, S-ketamine
What is being tested?
Esketamine and normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
2 sitesChina
Study dates
23 Sep 2024to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • First Medical center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, China

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Effect of a Single Dose of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery: a Randomized Controlled Trial

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

Read the 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 of anxiety and depression in patients. Approximately one-third of patients after cardiac surgery experience anxiety or depression, which increases the risk of recurrent cardiovascular events and death.

Ketamine is an anesthetic drug with comprehensive effects, including analgesia, sedation, and amnesia. Its primary mechanism of action is blocking N-methyl-D-aspartate (NMDA) receptors. Esketamine, the pure dextro isomer of ketamine, has a higher affinity for glutamate NMDA receptors and opioid receptors, offering stronger sedative, analgesic, and antidepressant effects. On March 4, 2019, esketamine was approved by the FDA for treatment-resistant depression. Given its analgesic, anesthetic, and antidepressant effects, esketamine may be an ideal drug for improving negative moods in patients undergoing cardiac surgery.

Being tested
Esketamine, normal saline
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsketamineDrug

    A single dose of 0.3mg / kg esketamine during induction of anesthesia.

  • normal salineDrug

    Receiving the same volume of normal saline during induction of anesthesia.

Study groups in NCT06608030
Study groupRoleWhat they receive
Esketamine groupExperimentalPatients who undergo general anesthesia using esketamine.
Receives: Drug: Esketamine
Control groupPlacebo comparatorPatients who undergo general anesthesia without esketamine
Receives: Drug: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative anxiety and depreession

    The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.

    Measured: Preoperative day 1, postoperative day 7 and day 30

Secondary outcomes (6)

  1. Postoperative Sleep Quality

    Postoperative sleep quality was assessed using the Insomnia Severity Index (ISI). The ISI is a simple tool used to screen for insomnia and consists of 7 items to assess the nature and symptoms of the subject\'s sleep disorder on a 5-point Likert scale, with each item scored from 0 to 4 and the total score ranging from 0 to 28, with higher scores indicating greater severity of insomnia. The sum of the scores with 0-7 indicating insomnia without clinical significance, 8-14 indicating subclinical insomnia, 15-21 indicating clinical insomnia (moderate), 22-28 indicating 'clinical insomnia (moderate), and 22-28 indicating clinical insomnia (moderate). A score of 8 to 14 indicates subclinical insomnia, a score of 15 to 21 indicates clinical insomnia (moderate), and a score of 22 to 28 indicates clinical insomnia (severe).

    Measured: Preoperative day 1, postoperative day 7 and day 30

  2. Delirium

    Delirium was assessed using a combination of the 3-Minute Diagnostic Interview for CAM (3D-CAM) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patients in the general ward were assessed using the 3D-CAM, while patients in the intensive care unit were assessed using the CAM-ICU. Delirium consists of four main features: acute altered mental status or fluctuating level of consciousness, inattention, disorganized thinking, and altered level of consciousness. Patients were diagnosed with postoperative delirium if both the first and second features were present, and either the third or fourth feature was also present.

    Measured: Within 7 days after surgery

  3. PONV

    Postoperative nausea and vomiting (PONV) were assessed using a visual analogue scale (VAS). This scale consists of a 10-centimeter straight line, with 0 indicating no nausea and vomiting, and 10 indicating the most extreme level of nausea and vomiting that can be endured. The severity of PONV is categorized as follows: mild (1 to 4), moderate (5 to 6), and severe (7 to 10).

    Measured: Within 2 days after extubation

  4. Postoperative Recovery Quality

    Postoperative quality of recovery was evaluated using the Chinese version of the Quality of Recovery-15 (QoR-15) score. This assessment tool comprises 15 items, each scored on a 10-point scale. The total score ranges from 0 to 150, with 0 indicating poor recovery and 150 signifying an excellent quality of recovery.

    Measured: Postoperative day 7 and day 30

  5. Postoperative Pain

    Assessment was conducted using the Numerical Rating Scale (NRS) for pain, which ranges from 0 to 10. On this scale, a score of 0 represents the absence of pain, while a score of 10 represents the most severe pain.

    Measured: Postoperative day 7 and day 30

  6. Postoperative Quality of Life

    Postoperative quality of life was evaluated using the EQ-5D, a five-dimensional health scale. This scale encompasses five key dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is rated on a three-point scale: no difficulty, some difficulty, and extreme difficulty. The responses to these levels are then utilized to calculate the EQ-5D Index score, which quantifies the overall health status based on the reported levels of difficulty across the five dimensions.

    Measured: Postoperative day 7 and day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start23 Sep 2024
  3. Primary completion7 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06608030
Sponsor's protocol ID
PLAGH-RCT-Esket
Status last verified
Apr 2025
First submitted
19 Sep 2024
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang ZN, Hao XY, Cai C, Sun L, Zhang ZY, Wang M, Wu YS, Wang Y, Cao JB, Liu YH, Lou JS, Fu Q, Jiang SL, Han RQ, Mi WD, Tong L. Effect of esketamine on postoperative depression and anxiety in patients undergoing cardiac valve surgery: A randomised, placebo-controlled, double-blinded clinical trial. Pharmacol Res. 2025 Dec;222:108047. doi: 10.1016/j.phrs.2025.108047. Epub 2025 Nov 22.

    PubMed 41285329

Questions about this trial

What is this clinical trial studying?

A study testing Esketamine and normal saline in people with Depression, Anxiety and Cardiac Surgery, run by Chinese PLA General Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative anxiety and depreession (time frame: Preoperative day 1, postoperative day 7 and day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06608030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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