Cardiac Surgery, Depression, Anxiety, S-ketamine
Conditions
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 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.
Interventions
DRUGEsketamine
A single dose of 0.3mg / kg esketamine during induction of anesthesia.
DRUGnormal saline
Receiving the same volume of normal saline during induction of anesthesia.
Sponsors
Beijing Tiantan Hospital
The Sixth Medical Center of Chinese PLA General Hospital
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perioperative acetylcholine (Ach) | perioperatively | Acetylcholine (Ach in ng/ml) |
| Perioperative norepinephrine (NE) | perioperatively | Norepinephrine(NE in ng/ml) |
| Intraoperative blood pressure | 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. |
| Intraoperatively heart rate | 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. |
| Perioperative inflammatory factor (IL-6) | perioperatively | Inflammatory factor (IL-6 in pg/ml) were from laboratory tests in the patient's medical record. |
| Perioperative inflammatory factor (CRP) | perioperatively | Inflammatory factor (CRP in mg/dl) were from laboratory tests in the patient's medical record. |
| Perioperative brain injury-related factor (S100β) | perioperatively | Brain injury-related factor (S100β in ng/ml) |
| Perioperative brain-derived neurotrophic factor (BDNF) | perioperatively | Brain-derived neurotrophic factor (BDNF in ng/ml) |
Countries
China
Outcome results
None listed