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NCT Number: NCT06608030

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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
  • Preoperative combined severe hepatic insufficiency or renal insufficiency 6. Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism

Treatment and study plan

Esketamine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Perioperative anxiety and depreession

    Time frame: Preoperative day 1, postoperative day 7 and day 30

    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.

Secondary outcomes

  1. Postoperative Sleep Quality

    Time frame: Preoperative day 1, postoperative day 7 and day 30

    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).

  2. Delirium

    Time frame: Within 7 days after surgery

    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.

  3. PONV

    Time frame: Within 2 days after extubation

    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).

  4. Postoperative Recovery Quality

    Time frame: Postoperative day 7 and day 30

    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.

  5. Postoperative Pain

    Time frame: Postoperative day 7 and day 30

    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.

  6. Postoperative Quality of Life

    Time frame: Postoperative day 7 and day 30

    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.

Other outcomes

  1. Intraoperative blood pressure

    Time frame: During the surgery

    Intraoperative blood pressure(MAP in mmHg/SBP in mmHg/DBP in mmHg) at T0 (before induction of anes thesia), T1 (5 min after esketamine or control injection), T2 (30 min after esketamine or control injection), T3 (1 h after esketamine or control injection), T4 (3 h after esketamine or control injection), and T5(at the end of surgery) were included.

  2. Intraoperatively heart rate

    Time frame: During the surgery

    Intraoperative heart rate(HR in bmp) at T0 (before induction of anes thesia), T1 (5 min after esketamine or control injection), T2 (30 min after esketamine or control injection), T3 (1 h after esketamine or control injection), T4 (3 h after esketamine or control injection), and T5(at the end of surgery) were included.

  3. Perioperative inflammatory factor (IL-6)

    Time frame: perioperatively

    Inflammatory factor (IL-6 in pg/ml) were from laboratory tests in the patient's medical record.

  4. Perioperative inflammatory factor (CRP)

    Time frame: perioperatively

    Inflammatory factor (CRP in mg/dl) were from laboratory tests in the patient's medical record.

  5. Perioperative brain injury-related factor (S100β)

    Time frame: perioperatively

    Brain injury-related factor (S100β in ng/ml)

  6. Perioperative brain-derived neurotrophic factor (BDNF)

    Time frame: perioperatively

    Brain-derived neurotrophic factor (BDNF in ng/ml)

  7. Perioperative acetylcholine (Ach)

    Time frame: perioperatively

    Acetylcholine (Ach in ng/ml)

  8. Perioperative norepinephrine (NE)

    Time frame: perioperatively

    Norepinephrine(NE in ng/ml)

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Tiantan Hospital
  • Navy General Hospital, Beijing

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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