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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
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Delirium is a frequent postoperative complication. Its occurrence is associated with worse long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose dexmedetomidine infusion during the early postoperative period decreased the incidence of delirium in elderly patients after surgery. The purpose of this 3-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 3-year outcome in elderly patients recruited in the previous randomized controlled trial.
Delirium is a frequent postoperative complication; a systematic review revealed that postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases with age. The occurrence of delirium is associated with worse long-term outcomes including worse functional recovery, decline in cognitive function, and increased mortality rate. Surgical stress, pain, and sleep disturbances are important factors leading to postoperative delirium in the elderly.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia.
In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo [normal saline] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% [79/350] with placebo vs. 9.1% [32/350] with dexmedetomidine; Odds Ratio 0.35, 95% Confidence Interval 0.22 to 0.54; p < 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population.
The purpose of this 3-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 3-year outcome in elderly patients recruited in the previous randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine group | Experimental | For patients who were not intubated, dexmedetomidine was infused at a rate of 0.1 microgram/kg per hour from study recruitment on the day of surgery until 8:00 am on the first day after surgery. For patients who were intubated and mechanically ventilated, dexmedetomidine infusion was started after the Richmond Agitation Sedation Scale was -2 or higher after intensive care unit admission until 8:00 am on the first day after surgery. |
|
| placebo group | Placebo Comparator | Normal saline was infused in the same rate for the same duration as that in the placebo group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | low-dose dexmedetomidine infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of survival after surgery | Duration of survival after surgery | From the day of surgery until the end of the 3rd year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates after surgery | Survival rates at different timepoints after surgery | At 6 months, 1 year, 2 years and 3 years after surgery |
| Cognitive function in 3-year survivors after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates in the subgroup of patients after cancer or non-cancer surgery | Survival rates at different timepoints in the subgroup of patients after cancer or non-cancer surgery | At 6 months, 1 year, 2 years and 3 years after surgery |
| Duration of survival in the subgroup of patients after cancer or non-cancer surgery |
Inclusion Criteria:
Patients were included if they met all of the following criteria:
Exclusion Criteria:
Patients were excluded if they met any of the following 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 |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8208869 | Background | Rabe-Jablonska J, Bienkiewicz W. [Anxiety disorders in the fourth edition of the classification of mental disorders prepared by the American Psychiatric Association: diagnostic and statistical manual of mental disorders (DMS-IV -- options book]. Psychiatr Pol. 1994 Mar-Apr;28(2):255-68. Polish. | |
| 7864702 | Background |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | normal saline infusion |
|
|
Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M).
| At the end of the 3rd year after surgery |
| Health related quality of life in 3-year survivors after surgery | Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF). | At the end of the 3rd year after surgery |
Duration of survival in the subgroup of patients after cancer or non-cancer surgery |
| From the day of surgery until the end of the 3rd year after surgery |
| Cognitive function in the subgroup of 3-year survivors after cancer or non-cancer surgery | Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M). | At the end of the 3rd year after surgery |
| Health related quality of life in the subgroup of 3-year survivors after cancer or non-cancer surgery | Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF). | At the end of the 3rd year after surgery |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |