Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT04204798
Sleep disorder and delirium are common problems in intensive care unit (ICU) patients, and may lead to poor prognosis. The investigators' previous study showed that nighttime infusion of low-dose dexmedetomidine improved the sleep quality and decreased the incidence of delirium in ICU patients after surgery. Long-term follow-up of these patients showed that low-dose dexmedetomidine also improved 2-year survival and the quality of life in 3-year survivors. The purpose of this study is to investigate the effect of low-dose dexmedetomidine on the long-term outcome of elderly patients admitted to the ICU after noncardiac surgery.
This study is active but is not currently recruiting participants.
Notify Me65 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100034, China
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anti-anxiety properties. Unlike other sedative agents, dexmedetomidine exerts its sedative effects through an endogenous sleep-promoting pathway, producing a state like non-rapid eye movement sleep. For mechanically ventilated patients, sedative-dose dexmedetomidine infusion at night maintains circadian rhythm, increases sleep efficiency, and improves sleep architecture. When used for sedation in mechanical ventilated patients, it reduces the incidence of delirium.
Dexmedetomidine may improve patient outcomes by improving sleep quality. A previous randomized trial found that, for elderly patients who were admitted to ICU after noncardiac surgery, nighttime infusion of low-dose dexmedetomidine significantly improves the sleep quality and decreases the incidence of postoperative delirium. A long-term follow-up of these patients showed that low-dose dexmedetomidine infusion significantly increased survival up to 2 years, and improved cognitive function and quality of life in 3-year survivors.
In the study mentioned above, dexmedetomidine was only infused during the night after surgery with a fixed dose. The investigators hypothesize that, for elderly admitted to ICU after surgery, nighttime infusion of individualized low-dose dexmedetomidine may improve long-term outcomes. This randomized controlled trial is designed to investigate the effect of low-dose dexmedetomidine on 1-year survival and the quality of life of 1-year survivors in elderly patients admitted to the ICU after surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Normal saline
Time frame: Up to 4 years after surgery
Overall survival after surgery
Time frame: Up to 5 days after surgery
Organ injury include delirium (assessed with Confusion Assessment Method/CAM for the Intensive Care Unit), acute kidney injury (assessed with KIDGO criteria), and myocardial injury (assessed with cardiac troponin I).
Time frame: Up to 30 days after surgery
Length of ICU stay after surgery
Time frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Postoperative complications are defined as newly occured medical events that are harmful to patients' recovery and required interventional therapy.
Time frame: Up to 30 days after surgery
All-cause 30-day mortality after surgery
Time frame: At 30 days after surgery
The sleep quality is assessed with the Pittsburgh Sleep Quality Index Questionnaire (PSQI, score ranges from 0 to 21, with higher score indicating poorer sleep quality).
Time frame: Up to 4 year after surgery
Recurrence-free survival after surgery
Time frame: Up to 4 year after surgery
Event-free survival after surgery
Time frame: Up to 4 year after surgery
Cancer-specific survival after surgery
Time frame: At the end the 1st year after surgery
The quality of life is assessed with the World Health Organization Quality of Life Questionaire abbreviated version (WHOQOL-BREF, a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).
Time frame: Up to 5 days after surgery.
Pain severity is assessed with the Numeric Rating Scale (an 11-point scale where 0=no pain and 10=the worst pain.
Time frame: Assessed in the morning on the 1st, 2nd, 3rd, 4th, and 5th day after surgery
Subjective sleep quality the Numeric Rating Scale (an 11-point scale where 0=the best sleep and 10=the worst sleep.
Time frame: Up to 4 year after surgery
Overall survival after surgery in cancer patients
Time frame: Up to 4 year after surgery
Recurrence-free survival after surgery in cancer patients
Time frame: Up to 4 year after surgery
Event-free survival after surgery in cancer patients
Time frame: Up to 4 year after surgery
Cancer-specific survival after surgery in cancer patients
Peking University First Hospital
Other
Impact of Low-dose Dexmedetomidine on Outcomes of Elderly Admitted to ICU After Noncardiac Surgery: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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