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This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.
To evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new "guidelines"; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. The central stochastic system was adopted to determined the stratification factors by age, POSSUM score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. Therefore, there are two groups including the new version of "guidelines" anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. The mortality is the primary indicator will be collected in 1,6,12 months after surgery. And VAS score, MMSE, length of hospital stay and so forth, which would be collected as the secondary indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New "guideline" | Experimental | New "guideline" anesthesia strategy team (Group A) |
|
| Current strategy | No Intervention | Current anesthesia strategy team (Group B) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New "guideline" anesthesia strategy team | Procedure | New "guideline" anesthesia strategy team |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality in 6 months of postoperative | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score(VAS) | The intensity of postoperative pain using Visual Analogue Score(VAS), has a total score of 10 range from 0 to 10. Do higher values represent a severer pain. | within two days after surgery |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 32500 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2018 | Jan 29, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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The incidence of postoperative complications
| post-operation to discharge, an average of 2 weeks |
| Death rate | Mortality for postoperative of 30 days and 1 year | Within 30 days and 1 year after surgery |
| Survival time | Observed length of time after surgery to death within one year | up to one year after surgery |
| Compliance score | The level of compliance of new "guideline"(from the ratio of (score:total score)), the ratio from 0% to 100% | Duration of hospital stay, an average of 2 weeks |
| Hospital stay | Length of time stay in hospital | Up to discharge,an average of 2 weeks |
| Cost | Total cost in hospital and expenditure for anesthesia | Length of hospital stay,an average of 2 weeks |
| MMSE | Cognitive function with Mini-Mental State Examination (MMSE) | Two days after surgery |
| Satisfaction score | Overall satisfaction of patients, with a range of 0 to 5 points. 0 point represents not satisfied at all and 5 points mean greatly satisfied. | Two weeks before discharge |
| D007869 |
| Leg Injuries |