Cardiac Surgery, Cardiopulmonary Bypass, Delirium, Dexmedetomidine, Survival
Conditions
Keywords
Cardiac Surgery, Cardiopulmonary Bypass, Dexmedetomidine, Delirium, Survival
Brief summary
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.
Detailed description
Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. The development of delirium is a consequence of multiple factors. For patients undergoing cardiac surgery, surgical stress and/or cardiopulmonary bypass can produce hyper-inflammatory and stress response, both of which are important factors leading to delirium. Meanwhile, patients in ICU after major surgery often develop sleep disturbances, which are also associated with increased risk of delirium. Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anxiolytic properties. In previous studies of elderly patients admitted to ICU after non-cardiac surgery, continuous infusion of low-dose dexmedetomidine during nighttime improves sleep quality, reduces delirium, and improves 2-year survival. The investigators hypothesize that, for patients admitted to ICU after cardiac surgery, nighttime infusion of low-dose dexmedetomidine can decrease the incidence of delirium and improve long-term survival. The purpose of this study is to investigate the effect of nighttime infusion of low-dose dexmedetomidine on postoperative sleep quality, delirium, and 2-year survival in elderly patients admitted to ICU after cardiac surgery.
Interventions
DRUGDexmedetomidine
Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery in the intensive care unit; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.
DRUGPlacebo
Placebo (normal saline) infusion is administered in the same rate for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.
Sponsors
Dong-Xin Wang
Fu Wai Hospital, Beijing, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥60 years but \<90 years; 2. Scheduled to undergo cardiac surgery with cardiopulmonary bypass under general anesthesia; 3. Expected to stay in the intensive care unit (ICU) for at least 1 night after surgery.
Exclusion criteria
Patients who meet any of the following criteria will be excluded. 1. Refuse to participate in the study; 2. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 3. Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or the snoring, tiredness, observed apnea, high blood pressure-body mass index, age, neck circumference and gender \[STOP-Bang\] questionnaires ≥3); 4. Inability to communicate during the preoperative period because of coma, profound dementia or language barrier; 5. Preoperative sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree atrioventricular block or above without pacemaker; 6. Severe hepatic dysfunction (Child-Pugh class C); 7. Severe renal dysfunction (requirement of renal replacement therapy) before surgery; 8. Presence of delirium (diagnosed by the Confusion Assessment Method \[CAM\]/CAM for the Intensive Care Unit \[CAM-ICU\]); 9. Current treatment with dexmedetomidine or clonidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium within the first 5 days after surgery | During the first 5 days after surgery | Delirium is assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the Confusion Assessment Method (CAM, for patients without mechanical ventilation) or CAM for the intensive care unit (CAM-ICU, for patients with mechanical ventilation) during postoperative days 1-5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation after surgery | Up to 30 days after surgery | Duration of mechanical ventilation after surgery |
| Length of stay in ICU after surgery | Up to 30 days after surgery | Length of stay in ICU after surgery |
| Length of stay in hospital after surgery | Up to 30 days after surgery | Length of stay in hospital after surgery |
| Incidence of Major Adverse Cardiovascular Events (MACEs) within 30 days after surgery | Up to 30 days after surgery | Postoperative Major Adverse Cardiac Events (MACEs) include in-hospital death, myocardial infarction, second surgery, non-fetal cardiac arrest/ventricular fibrillation, and stroke. The occurrence of major postoperative events is followed up twice daily during postoperative days 1-5, then once a week until 30 days after surgery. |
| Incidence of other complications | Up to 30 days after surgery | Incidence of other complications (including hospital re-admission) within 30 days after surgery. |
| All-cause 30-day mortality | At 30 days after surgery | All-cause mortality within 30 days after surgery |
| Subjective sleep quality at 30 days after surgery | At 30 days after surgery | Subjective sleep quality at 30 days after surgery is assessed with Pittsburgh sleep quality index (PSQI) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD, PhD
Peking University First Hospital
Outcome results
None listed