Effect of Dexmedetomidine on Central Nervous System Complications in Patients Undergoing Cardiac Surgery
NCT Number: NCT06551259
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Randomized Controlled Trial|Dexmedetomidine
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2024-08-30

Summary:
With the continuous improvement of medical technology, more and more patients need to undergo surgery as a kind of treatment for their diseases. However, there are various pains that may occur in the perioperative period, risks associated with anesthesia, loss of body organs, surgical trauma, and postoperative procedures Factors such as the onset of the disease can cause the vast majority of patients to have varying degrees of emotional reactions such as worry, worry, nervousness, and fear. Emotional disorders such as depressed mood, disappointed crying, decreased mobility, and delayed thinking and cognitive function, that is, postoperative psychiatric symptoms.

Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine. Releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. Previous studies have shown that dexmedetomidine is lowering. DEX has the potential to prevent and treat patients undergoing cardiac surgery. The role of postoperative anxiety and depression needs to be further explored for evidence-based evidence. Based on the above research background, the hypothesis of this study is proposed. The intraoperative use of dexmedetomidine has a positive effect on alleviating postoperative anxiety and depression in patients undergoing postoperative cardiac surgery.

Primary Outcome Measures: The incidence of postoperative depression, Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms, Postoperative 7 days and 30 days
Secondary Outcome Measures: The incidence of postoperative anxiety, Generalized Anxiety Disorder-7 (GAD-7) Scale to Assess Anxiety Symptoms, Postoperative 7 days and 30 days|The incidence of postoperative delirium, Patients in the 3-Minute Diagnostic Interview for CAM (3D-CAM) general ward are evaluated by 3D-CAM. Delirium consists of four main features: acute altered mental status or fluctuating levels of consciousness, difficulty concentrating, confusion, and altered levels of consciousness. If both the first and second features are present, and the third or fourth feature is present, the patient is diagnosed with postoperative delirium., Postoperative 7 days|Postoperative Pain, NRS Pain Scoring Criteria (0-10): NRS is 0-10, with 0 indicating no pain and 10 indicating the worst pain. The total amount of analgesic drug consumption and the number of PCIA active compressions within 48 hours were recorded every day, Postoperative 7 days and 30 days|Postoperative quality of life evaluation, Five-dimensional health scale EQ-5D, the five-dimensional health scale consists of 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression. Each dimension contains three levels: no difficulty, some difficulty, and extreme difficulty. Through the conversion of effect size, the respondents can make choices at the five dimensions and three levels in the questionnaire, and calculate the score of the five-dimensional health scale index., Postoperative 30 days|Postoperative mortality rate, Follow-up by phone or mail for patient mortality., Postoperative 7 days and 30 days|Surgical related complications, Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery., Postoperative 7 days|Postoperative sleep quality, Postoperative sleep quality was measured using the Pittsburgh Sleep Quality Index scale., Postoperative 7 days and 30 days