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| Name | Class |
|---|---|
| Shandong Institute of Science and Technology Information | OTHER |
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Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.
SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SFI intervention group | Experimental | shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop. |
|
| Control group | Sham Comparator | same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shen-Fu injection | Drug | Chinese patent medicine made by modern technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative delirium within 7 days | postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together. | day 1-7 after surgery, more scores means higher incidence of POD |
| Measure | Description | Time Frame |
|---|---|---|
| non-delirium complications | postoperative complications except for delirium | day 1-7 after surgery |
| length of stay | length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhang weiliang | Contact | 13365316885 | hezhangweiliang@163.com | |
| zhang xin | Contact | 0531-68616733 |
| Name | Affiliation | Role |
|---|---|---|
| zhang xin | Shandong University of Traditional Chinese Medicine | Study Director |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C492793 | Shen-Fu |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline | Drug | 0.9% normal saline, used for sham control |
|
|
| approximately day 1 in hospital to day 7 |
| pain assessment within 3 days | postoperative pain estimated with Numerical Rating Scale | day 1-3 after surgery, higher scores mean more pain. |
| all-caused mortality within 30 days | short-term follow up | 30 days after surgery |
| survival in 1 year | long-term follow up | 1 year discharge from hospital |
| adverse events to shenfu injection | adverse events caused form shenfu injection | approximately day1-7 after surgery |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |