Dexmedetomidine and Delirium in Patients After Cardiac Surgery
Condition: Delirium; C.Surgical Procedure; Cardiac; Postoperative Complications
MeSH terms: Delirium; Postoperative Complications
Intervention: dexmedetomidine hydrochloride for injection; 0.9% sodium chloride for injection
Intervention description: Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml).
Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 μg/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 μg /kg/h) until the end of surgery.
At the end of surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation after surgery.; Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared.
Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery.
At the end of surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation after surgery.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 285.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Delirium; Cardiac Surgical Procedures; Postoperative Complications; Dexmedetomidine; Prevention

Summary:

      Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery.
      Its occurrence is associated with worse outcomes of patients, including increased morbidity,
      prolonged hospital stay, increased medical cost, and higher mortality. It is also associated
      with long-term cognitive decline and decreased quality of life. However, until recently,
      pharmacological interventions that can effectively prevent its occurrence are still limited.
      The purpose of this study is to investigate whether perioperative dexmedetomidine use can
      decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or
        valve replacement surgery)

        Exclusion Criteria:

        Patients will be excluded if they meet any of the following criteria:

          1. Refuse to participate;

          2. Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe
             dementia;

          3. Inability to communicate in the preoperative period because of severe visual/auditory
             dysfunction or language barrier;

          4. History of brain injury or neurosurgery;

          5. Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or
             above atrioventricular block without pacemaker;

          6. Severe hepatic dysfunction (Child-Pugh class C);

          7. Severe renal dysfunction (requirement of renal replacement therapy);

          8. Other conditions that are considered unsuitable for participation.