Postoperative Delirium
Conditions
Brief summary
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
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.
Interventions
DRUGShen-Fu injection
Chinese patent medicine made by modern technology
DRUGnormal saline
0.9% normal saline, used for sham control
Sponsors
Shandong Institute of Science and Technology Information
Shandong University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative delirium within 7 days | day 1-7 after surgery, more scores means higher incidence of POD | postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of stay | approximately day 1 in hospital to day 7 | length of hospital stay |
| pain assessment within 3 days | day 1-3 after surgery, higher scores mean more pain. | postoperative pain estimated with Numerical Rating Scale |
| non-delirium complications | day 1-7 after surgery | postoperative complications except for delirium |
| survival in 1 year | 1 year discharge from hospital | long-term follow up |
| adverse events to shenfu injection | approximately day1-7 after surgery | adverse events caused form shenfu injection |
| all-caused mortality within 30 days | 30 days after surgery | short-term follow up |
Contacts
Primary Contactzhang weiliang
Backup Contactzhang xin
Outcome results
None listed