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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR1800017182 | Registry Identifier | Chinese Clinical Trial Registry (www.chictr.org.cn) |
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| Name | Class |
|---|---|
| Beijing Jishuitan Hospital | OTHER |
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Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.
A growing number of elderly patients undergo orthopedic surgery each year. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. The investigators hypothesize that dexmedetomidine supplemented intravenous analgesia (in the form of patient-controlled analgesia) can also reduce delirium and improve long-term outcomes in elderly patients after orthopedic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of patient-controlled intravenous analgesia. The formula contains a mixture of sufentanil (1.25 ug/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a patient-controlled bolus of 2 ml each time and a lockout interval of 8 minutes. |
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| Control group | Placebo Comparator | For patients in the control group, postoperative analgesia is provided in the form of patient-controlled intravenous analgesia. The formula contains a mixture of placebo and sufentanil (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a patient-controlled bolus of 2 ml each time and a lockout interval of 8 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and sufentanil (1.25 ug/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium within the first 5 days after surgery | Incidence of delirium within the first 5 days after surgery | The first 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Daily prevalence of delirium during the first 5 days after surgery | Daily prevalence of delirium during the first 5 days after surgery | The first 5 days after surgery |
| Length of stay in hospital after surgery |
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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 | ||
| Beijing Jishuitan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7864702 | Background | Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461. | |
| 22732435 | Background | McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of placebo and sufentanil (1.25 ug/m), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes. |
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Length of stay in hospital after surgery
| Up to 30 days after surgery |
| Incidence of non-delirium complications with 30 days after surgery | Incidence of non-delirium complications with 30 days after surgery | Up to 30 days after surgery |
| All-cause 30-day mortality | All-cause 30-day mortality | Up to 30 days after surgery |
| Quality of life of 30-day survivors | Quality of life of 30-day survivors is assessed with World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function. | At 30 days after surgery |
| Cognitive function of 30-day survivors | Cognitive function of 30-day survivors is assessed with the modified Telephone Interview for Cognitive Status (TICS-m), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 48, with higher score indicating better function. | At 30 days after surgery |
| Agitation or sedation level during postoperative days 1-5 | Agitation or sedation level is assessed twice daily with the Richmond Agitation-Sedation Scale (RASS), of which the range is as follows: +4 (combative), +3 (very agitated), +2 (agitated), +1 (restless), 0 (alert and clam), -1 (drowsy), -2 (light sedation), -3 (moderate sedation), -4 (deep sedation), and -5 (unarousable). | The first 1-5 days after surgery |
| Cumulative sufentanil consumption within 5 postoperative days | Cumulative sufentanil consumption within 5 postoperative days | Up to 5 days after surgery |
| Pain severity during postoperative days 1-5 | Pain severity is assessed with twice daily the Numeric Rating Scale (NRS), an 11 point scale where 0=no pain and 10=the worst possible pain. | The first 1-5 days after surgery |
| Subjective sleep quality during postoperative days 1-5 | Subjective sleep quality is assessed once daily with the Numeric Rating Scale (NRS), an 11 point scale where 0=the best sleep and 10=the worst sleep. | The first 1-5 days after surgery |
| Overall survival for up to 3 years after surgery | Time from surgery to all-cause death for up to 3 years after surgery. | Up to 3 years after surgery |
| Event-free survival for up to 3 years after surgery | Time from surgery to new-onset diseases or all-cause death, whichever comes first. New-onset disease indicates those that required hospital admission and/or interventional procedure. | Up to 3 years after surgery |
| Quality of life in 1-，2- and 3-year survivors after surgery | Quality of life in 1-，2- and 3-year survivors is assessed with the WHOQOL-BREF, a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function. | At the end of the 1st, 2nd, and 3rd year after surgery |
| Cognitive function in 1-，2- and 3-year survivors after surgery | Cognitive function in 1-，2- and 3-year survivors is assessed with the TICS-m, a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 48, with higher score indicating better function. | At the end of the 1st, 2nd, and 3rd year after surgery |
| Beijing |
| Beijing Municipality |
| 102208 |
| China |
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| 34517840 | Derived | Hong H, Zhang DZ, Li M, Wang G, Zhu SN, Zhang Y, Wang DX, Sessler DI. Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial. BMC Anesthesiol. 2021 Sep 13;21(1):223. doi: 10.1186/s12871-021-01441-3. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |