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Clinical Trials/NCT04488952
NCT04488952
Unknown
Not Applicable

The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial

Shenzhen Second People's Hospital1 site in 1 country350 target enrollmentJuly 8, 2020
ConditionsPND

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PND
Sponsor
Shenzhen Second People's Hospital
Enrollment
350
Locations
1
Primary Endpoint
Incidence of PND seven days after surgery
Last Updated
4 years ago

Overview

Brief Summary

Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the elderly, especially in the plastic surgery. Different anesthesia methods have different incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve block combined with general anesthesia. We will apply a psychometric battery test which contain different cognitive domains to estimate the incidence of PND at a week a month and a year after surgery with different anesthesia methods. Study has showed that functional magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology is used to conduct in-depth research on MRI and make correlation analysis with cognitive function.

Registry
clinicaltrials.gov
Start Date
July 8, 2020
End Date
June 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shenzhen Second People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

ZhiHeng Liu

Chair of Department of Anesthesiology

Shenzhen Second People's Hospital

Eligibility Criteria

Inclusion Criteria

  • aged 60-85years
  • ASA I-III
  • Received elective surgery of unilateral lower extremity orthopedics
  • The anesthesia lasted more than 2 hours

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of PND seven days after surgery

Time Frame: seven days after surgery

Secondary Outcomes

  • ADL of temporal lobe(one day pre-operation, one week post-operation)
  • ADL of occipital lobe(one day pre-operation, one week post-operation)
  • Incidence of PND one month after surgery(one month after surgery)
  • One year event-free survival(one year after surgery)
  • Incidence of PND one year after surgery(one year after surgery)
  • Hospital stay(one to two weeks after surgery)
  • Number of patients entrance the ward of ICU after surgery(one week post-operation)
  • Mortality rate(one year after surgery)
  • Postoperative complications(one month post-operation)
  • ADL of frontal lobe,temporal lobe and occipital lobe(one day pre-operation, one week post-operation)
  • ADL of frontal lobe(one day pre-operation, one week post-operation)
  • BOLD of the whole brain(one day pre-operation, one week post-operation)

Study Sites (1)

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