Delirium Clinical Trial
Official title:
Effect of Low-dose Dexmedetomidine on Postoperative Delirium in Patients After Cardiac Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
Verified date | May 2024 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 502 |
Est. completion date | August 2024 |
Est. primary completion date | July 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing University First Hospital | Beijing | Beijing |
China | Fuwai Hospital of Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Dong-Xin Wang | Fu Wai Hospital, Beijing, China |
China,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Alterations of sleep architecture | Sleep architecture is monitored with polysomnograph from 21:00 pm in the night of surgery to 06:00 am on the first day after surgery in part of enrolled patients (selected according to randomization block). | During the night of surgery | |
Other | The Numeric Rating Scale (NRS) pain score within 5 days after surgery. | The Numeric Rating Scale (NRS) pain score is assessed with the NRS (an 11-point scale where 0=no pain and 10=the worst pain). | At 2, 6, 24, 48, 72, 96, and 120 hours (i.e., the 5th day) after surgery. | |
Other | Subjective sleep quality within 5 days after surgery | Subjective sleep quality is assessed with NRS (an 11-point scale where 0=the best sleep and 10=the worst sleep) once daily (8:00-10:00 am) during postoperative days 1-5. | During the first 5 days after surgery | |
Other | Daily prevalence of delirium during postoperative days 1-5 | Daily prevalence of delirium during postoperative days 1-5 | During the first 5 days after surgery | |
Primary | Incidence of delirium within 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. | During the first 5 days after surgery | |
Secondary | Duration of mechanical ventilation after surgery | Duration of mechanical ventilation after surgery | Up to 30 days after surgery | |
Secondary | Length of stay in ICU after surgery | Length of stay in ICU after surgery | Up to 30 days after surgery | |
Secondary | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery | |
Secondary | Incidence of Major Adverse Cardiovascular Events (MACEs) within 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. | Up to 30 days after surgery | |
Secondary | Incidence of other complications | Incidence of other complications (including hospital re-admission) within 30 days after surgery. | Up to 30 days after surgery | |
Secondary | All-cause 30-day mortality | All-cause mortality within 30 days after surgery | At 30 days after surgery | |
Secondary | Subjective sleep quality at 30 days after surgery | Subjective sleep quality at 30 days after surgery is assessed with Pittsburgh sleep quality index (PSQI) | At 30 days after surgery | |
Secondary | 2 -year Major Adverse Cardiac and Cerebrovascular Events (MACCEs)-free survival after surgery | Major Adverse Cardiac and Cerebrovascular Events (MACCEs) include cardiac death, myocardial infarction, revascularization, and stroke. | Up to 2 years after surgery | |
Secondary | 2-year overall survival after surgery | 2-year survival overall after surgery | Up to 2 years after surgery | |
Secondary | Cognitive function in 1- and 2-year survivors | Cognitive function in 1- and 2-year survivors is assessed with the modified Telephone Interview for Cognitive Status (TICS-m, score ranges from 0 to 40, with higher score indicating better function). | At the end of the 1st and 2nd years after surgery | |
Secondary | Quality of life in 1- and 2- year survivors | Quality of life in 1- and 2-year survivors is assessed with the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates 8 different domains of quality of life, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The score of each domain ranges from 0 to 100, with high score indicating better function. | At the end of the 1st and 2nd years after surgery |
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