Dexmedetomidine, Randomized Controlled Trial
Conditions
Brief 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.
Detailed description
1. Observing the effect of intraoperative use of dexmedetomidine on the incidence of postoperative anxiety and depression in patients undergoing cardiac surgery; 2. Observe the effects of intraoperative use of dexmedetomidine on postoperative delirium, quality of life, pain scores, and sleep quality in patients undergoing cardiac surgery; 3. To provide a feasible plan for preventing and treating postoperative anxiety and depression in patients undergoing cardiac surgery, improve the quality of patient prognosis, and reduce the burden on society.
Interventions
DRUGDexmedetomidine
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
DRUGphysiological saline
physiological saline
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age range from 18 to 85 years old, regardless of gender 2. Patients who undergo cardiac surgery on a scheduled basis; 3. ASA level 1-4; 4. Obtain written informed consent form;
Exclusion criteria
1. Patients with MMSE scores less than 18 or dementia, intellectual disability, and inability to communicate (coma, severe dementia, hearing or language impairment); 2. Have a history of mental or neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis); 3. Previous history of brain injury; 4. Severe liver dysfunction (Child pugh C-grade) or renal insufficiency (preoperative dialysis); 5. Severe bradycardia (heart rate below 50 beats per minute), pathological sinus syndrome, or atrioventricular block without a pacemaker; 6. Postoperative intensive care unit (ICU) duration exceeding 7 days or death;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative depression | Postoperative 7 days and 30 days | Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative delirium | Postoperative 7 days | 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 Pain | Postoperative 7 days and 30 days | 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 quality of life evaluation | Postoperative 30 days | 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. |
| The incidence of postoperative anxiety | Postoperative 7 days and 30 days | Generalized Anxiety Disorder-7 (GAD-7) Scale to Assess Anxiety Symptoms |
| Surgical related complications | Postoperative 7 days | Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery. |
| Postoperative sleep quality | Postoperative 7 days and 30 days | Postoperative sleep quality was measured using the Pittsburgh Sleep Quality Index scale. |
| Postoperative mortality rate | Postoperative 7 days and 30 days | Follow-up by phone or mail for patient mortality. |
Countries
China
Outcome results
None listed