Clinical trial NCT03624595: Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery
Official title: Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Dexmedetomidine
Delirium
Survival
Keywords: Cardiac Surgery
Cardiopulmonary Bypass
Dexmedetomidine
Delirium
Survival
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Fu Wai Hospital, Beijing, China
First posted: 2018-08-10
Enrollment: 502
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of delirium within the first 5 days after surgery
timeFrame: During the first 5 days after surgery
Secondary outcomes:
measure: Duration of mechanical ventilation after surgery
timeFrame: Up to 30 days after surgery
measure: Length of stay in ICU after surgery
timeFrame: Up to 30 days after surgery
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of Major Adverse Cardiovascular Events (MACEs) within 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of other complications
timeFrame: Up to 30 days after surgery
measure: All-cause 30-day mortality
timeFrame: At 30 days after surgery
measure: Subjective sleep quality at 30 days after surgery
timeFrame: At 30 days after surgery
measure: 2 -year Major Adverse Cardiac and Cerebrovascular Events (MACCEs)-free survival after surgery
timeFrame: Up to 2 years after surgery
measure: 2-year overall survival after surgery
timeFrame: Up to 2 years after surgery
measure: Cognitive function in 1- and 2-year survivors
timeFrame: At the end of the 1st and 2nd years after surgery
measure: Quality of life in 1- and 2- year survivors
timeFrame: At the end of the 1st and 2nd years after surgery
Other outcomes:
measure: Alterations of sleep architecture
timeFrame: During the night of surgery
measure: The Numeric Rating Scale (NRS) pain score within 5 days after surgery.
timeFrame: At 2, 6, 24, 48, 72, 96, and 120 hours (i.e., the 5th day) after surgery.
measure: Subjective sleep quality within 5 days after surgery
timeFrame: During the first 5 days after surgery
measure: Daily prevalence of delirium during postoperative days 1-5
timeFrame: During the first 5 days after surgery
Locations:
city: Beijing
country: China
facility: Beijing University First Hospital
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital of Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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