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Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery

Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery: a Single-center Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03429010
Acronym
EPAPHUS
Enrollment
300
Registered
2018-02-12
Start date
2018-07-01
Completion date
2020-12-31
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hip Fracture Surgery, Nursing

Keywords

Anesthesia, Hip Fracture

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURENew guideline anesthesia strategy team

New guideline anesthesia strategy team

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients ≥ 75 years old; 2. Patients with hip fracture purely and surgical treatment is scheduled.

Exclusion criteria

1. Surgical treatment has been performed after entering hospital; 2. Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc. 3. Refuse to sign informed consent; 4. Investigator thinks he/she is inappropriate to carry out this study.

Design outcomes

Primary

MeasureTime frameDescription
Mortality6 months after surgeryMortality in 6 months of postoperative

Secondary

MeasureTime frameDescription
Visual Analogue Score(VAS)within two days after surgeryThe 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.
Complicationspost-operation to discharge, an average of 2 weeksThe incidence of postoperative complications
Death rateWithin 30 days and 1 year after surgeryMortality for postoperative of 30 days and 1 year
Compliance scoreDuration of hospital stay, an average of 2 weeksThe level of compliance of new guideline(from the ratio of (score:total score)), the ratio from 0% to 100%
Survival timeup to one year after surgeryObserved length of time after surgery to death within one year
CostLength of hospital stay,an average of 2 weeksTotal cost in hospital and expenditure for anesthesia
MMSETwo days after surgeryCognitive function with Mini-Mental State Examination (MMSE)
Satisfaction scoreTwo weeks before dischargeOverall satisfaction of patients, with a range of 0 to 5 points. 0 point represents not satisfied at all and 5 points mean greatly satisfied.
Hospital stayUp to discharge,an average of 2 weeksLength of time stay in hospital

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026