Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery
- Conditions
- Depression, AnxietyCardiac SurgeryS-ketamine
- Interventions
- Drug: normal saline
- Registration Number
- NCT06608030
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
A multi-center, randomized controlled, blinded prospective study to investigate the effect 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 mood such as anxiety and depression. The size and type of surgery have a significant impact on the occurrence of anxiety and depression in patients, and approximately 1/3 of patients after cardiac surgery have anxiety or depression, which increase the risk of recurrent cardiovascular events and death. Ketamine is a type of anesthetic drug with comprehensive effects, including analgesia, sedation, and amnesia. Its primary mechanism of action is blocking N-methyl-D-aspartate (NMDA) receptors. Esketamine is the pure dextro isomer of ketamine, which has a higher affinity for glutamate NMDA receptors and opioid receptors, and has stronger sedative, analgesic, and antidepressant effects. On March 4,2019, esketamine has been licensed by the FDA for treatment-resistant depression. Given its analgesic, anesthetic and antidepressant effects, esketamine may be an ideal drug for improving negative mood in patients undergoing cardiac surgery
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 142
- 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
- Previous psychiatric or neurological disorders;
- Personal history of mental retardation or preoperative Brief Mental State Examination Scale (MMSE) determination of impaired cognitive functioning or language deficits, and the patient's inability to cooperate with the investigator's psychiatric evaluation;
- Patients taking antipsychotics, antidepressants, glucocorticoids, alcohol or illicit drug abuse;
- History of uncontrolled hypertension, diabetes mellitus, oncology, haematological diseases ;
- Preoperative combined severe hepatic and renal insufficiency;
- Contraindications to the use of esketamine, such as refractory hypertension, hyperthyroidism.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esketamine group Esketamine Patients who undergo general anesthesia using esketamine. Control group normal saline Patients who undergo general anesthesia without esketamine
- Primary Outcome Measures
Name Time Method Perioperative anxiety and depreession 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 Outcome Measures
Name Time Method Postoperative Sleep Quality 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).
Delirium 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.
PONV 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).
Postoperative Recovery Quality 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.
Postoperative Pain 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.
Postoperative Quality of Life 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.
Trial Locations
- Locations (2)
Beijing Tiantan Hospital
🇨🇳Bejing, Beijing, China
First Medical center of Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China