A Phase 4 interventional study of Dexmedetomidine and physiological saline in Randomized Controlled Trial and Dexmedetomidine, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Chinese PLA General Hospital · Phase 4, Interventional, and Prevention
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.
Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
Intravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery
Drug: Dexmedetomidine
Provide equal volume of physiological saline
Drug: physiological saline
Intravenous infusion of 0.6μg/kg load dose of dexmedetomidine within 10 minutes after intubation, followed by continuous infusion at a rate of 0.4 μg/kg/h until 30 minutes before the end of surgery
physiological saline
The incidence of postoperative depression
Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms
Time frame: Postoperative 7 days and 30 days
The incidence of postoperative anxiety
Generalized Anxiety Disorder-7 (GAD-7) Scale to Assess Anxiety Symptoms
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Postoperative 30 days
Postoperative mortality rate
Follow-up by phone or mail for patient mortality.
Time frame: 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.
Time frame: Postoperative 7 days
Postoperative sleep quality
Postoperative sleep quality was measured using the Pittsburgh Sleep Quality Index scale.
Time frame: Postoperative 7 days and 30 days
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital