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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days. |
|
| Placebo group | Placebo Comparator | Normal saline is infused for the same duration as in the dexmedetomidine group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival after surgery | Overall survival after surgery | Up to 4 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of organ injury within 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). | Up to 5 days after surgery |
| Length of stay in the intensive care unit (ICU) stay after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity within 5 days after surgery: Numeric Rating Scale | Pain severity is assessed with the Numeric Rating Scale (an 11-point scale where 0=no pain and 10=the worst pain. | Up to 5 days after surgery. |
| Subjective sleep quality within 5 days after surgery: Numeric Rating Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10660851 | Background | Novaes MA, Knobel E, Bork AM, Pavao OF, Nogueira-Martins LA, Ferraz MB. Stressors in ICU: perception of the patient, relatives and health care team. Intensive Care Med. 1999 Dec;25(12):1421-6. doi: 10.1007/s001340051091. | |
| 11940739 | Background | Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52. doi: 10.1097/00003246-200204000-00004. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug |
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Length of ICU stay after surgery |
| Up to 30 days after surgery |
| Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery |
| Incidence of postoperative complications within 30 days after surgery | Postoperative complications are defined as newly occured medical events that are harmful to patients' recovery and required interventional therapy. | Up to 30 days after surgery |
| Rate of all-cause 30-day mortality after surgery | All-cause 30-day mortality after surgery | Up to 30 days after surgery |
| Sleep quality 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). | At 30 days after surgery |
| Recurrence-free survival after surgery | Recurrence-free survival after surgery | Up to 4 year after surgery |
| Event-free survival after surgery | Event-free survival after surgery | Up to 4 year after surgery |
| Cancer-specific survival after surgery | Cancer-specific survival after surgery | Up to 4 year after surgery |
| Quality of life in 1-year survivors 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). | At the end the 1st year after surgery |
Subjective sleep quality the Numeric Rating Scale (an 11-point scale where 0=the best sleep and 10=the worst sleep. |
| Assessed in the morning on the 1st, 2nd, 3rd, 4th, and 5th day after surgery |
| Overall survival after surgery in cancer patients | Overall survival after surgery in cancer patients | Up to 4 year after surgery |
| Recurrence-free survival after surgery in cancer patients | Recurrence-free survival after surgery in cancer patients | Up to 4 year after surgery |
| Event-free survival after surgery in cancer patients | Event-free survival after surgery in cancer patients | Up to 4 year after surgery |
| Cancer-specific survival after surgery in cancer patients | Cancer-specific survival after surgery in cancer patients | Up to 4 year after surgery |
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |