A multicenter, randomized controlled, blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
142
A single dose of 0.3mg / kg esketamine during induction of anesthesia.
Receiving the same volume of normal saline during induction of anesthesia.
First Medical center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
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.
Time frame: Preoperative day 1, postoperative day 7 and day 30
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).
Time frame: Preoperative day 1, postoperative day 7 and day 30
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.
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Time frame: Within 7 days after surgery
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).
Time frame: Within 2 days after extubation
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.
Time frame: Postoperative day 7 and day 30
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.
Time frame: Postoperative day 7 and day 30
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.
Time frame: Postoperative day 7 and day 30