Shenfu Injection for Postoperative Delirium (SFI for POD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Drug: Shen-Fu injection
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hip fracture surgery under epidural anesthesia Exclusion Criteria: Severe dementia, hearing/vision impairment, coma, etc., unable to communicate; patients with end-stage diseases such as tumor; 3 months after myocardial infarction, cerebral infarction; severe heart, liver and renal dysfunction.

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SFI intervention group<br>shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop. | Drug: Shen-Fu injection<br>* Chinese patent medicine made by modern technology<br>* Other names: sanjiu yaan;|
| Sham Comparator: Control group<br>same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop. | Drug: normal saline<br>* 0.9% normal saline, used for sham control<br>* Other names: physiological saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-delirium complications | postoperative complications except for delirium | day 1-7 after surgery | 
| length of stay | length of hospital stay | 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 |