Effect of Dexmedetomidine on Central Nervous System Complications in Patients Undergoing Cardiac Surgery

Phase 4

Completed

• Conditions: Randomized Controlled Trial; Dexmedetomidine

• Registration Number: NCT06551259
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2023-04-01
• Primary Completion: 2024-04-03
• Status Verified: 2024-08
• Study Completion: 2024-08-09
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative depression	Postoperative 7 days and 30 days	Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms

Secondary Outcome Measures

Name	Time	Method
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 mortality rate	Postoperative 7 days and 30 days	Follow-up by phone or mail for patient mortality.
Surgical related complications	Postoperative 7 days	Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.
The incidence of postoperative anxiety	Postoperative 7 days and 30 days	Generalized Anxiety Disorder-7 (GAD-7) Scale to Assess Anxiety Symptoms
Postoperative sleep quality	Postoperative 7 days and 30 days	Postoperative sleep quality was measured using the Pittsburgh Sleep Quality Index scale.
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.