Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery
NCT ID: NCT03624595
Last Updated: 2025-04-09
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
502 participants
INTERVENTIONAL
2019-04-16
2025-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dexmedetomidine group
Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery; 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.
Dexmedetomidine
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.
Placebo group
Placebo (normal saline) infusion is administered from 16:00 to 08:00 in the same speed 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.
Placebo
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.
Interventions
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Dexmedetomidine
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
90 Years
ALL
No
Sponsors
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Fu Wai Hospital, Beijing, China
OTHER
Dong-Xin Wang
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Beijing University First Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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References
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Other Identifiers
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2018-181
Identifier Type: -
Identifier Source: org_study_id
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