Skip to main content
OpenTrials
Completed

NCT Number: NCT06551259

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

About this study

  • Observing the effect of intraoperative use of dexmedetomidine on the incidence of postoperative anxiety and depression in patients undergoing cardiac surgery;
  • Observe the effects of intraoperative use of dexmedetomidine on postoperative delirium, quality of life, pain scores, and sleep quality in patients undergoing cardiac surgery;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range from 18 to 85 years old, regardless of gender
  • Patients who undergo cardiac surgery on a scheduled basis;
  • ASA level 1-4;
  • Obtain written informed consent form;

Exclusion criteria

  • Patients with MMSE scores less than 18 or dementia, intellectual disability, and inability to communicate (coma, severe dementia, hearing or language impairment);
  • Have a history of mental or neurological disorders (such as schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis);
  • Previous history of brain injury;
  • Severe liver dysfunction (Child pugh C-grade) or renal insufficiency (preoperative dialysis);
  • Severe bradycardia (heart rate below 50 beats per minute), pathological sinus syndrome, or atrioventricular block without a pacemaker;
  • Postoperative intensive care unit (ICU) duration exceeding 7 days or death;

Treatment and study plan

Dexmedetomidine

Drug

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

Drug

physiological saline

Primary outcomes

  1. The incidence of postoperative depression

    Time frame: Postoperative 7 days and 30 days

    Patient Health Questionnaire-9 (PHQ-9) scale assesses depressive symptoms

Secondary outcomes

  1. The incidence of postoperative anxiety

    Time frame: Postoperative 7 days and 30 days

    Generalized Anxiety Disorder-7 (GAD-7) Scale to Assess Anxiety Symptoms

  2. The incidence of postoperative delirium

    Time frame: 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.

  3. Postoperative Pain

    Time frame: 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

  4. Postoperative quality of life evaluation

    Time frame: 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.

  5. Postoperative mortality rate

    Time frame: Postoperative 7 days and 30 days

    Follow-up by phone or mail for patient mortality.

  6. Surgical related complications

    Time frame: Postoperative 7 days

    Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.

  7. Postoperative sleep quality

    Time frame: Postoperative 7 days and 30 days

    Postoperative sleep quality was measured using the Pittsburgh Sleep Quality Index scale.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Effect of Intraoperative Dextrometomidine on Complications of the Central Nervous System in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.