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The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly

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ClinicalTrials.gov Identifier: NCT04488952
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
ZhiHeng Liu, Shenzhen Second People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
PND Device: nerve block combined with general anesthesia Device: spinal anesthesia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: nerve block combined with general anesthesia group
Patients in this group receive nerve block combined with general anesthesia.
 Device: nerve block combined with general anesthesia
Patients in this group receive nerve block combined with general anesthesia.

Device: spinal anesthesia
Patients in this group receive spinal anesthesia.
Experimental: spinal anesthesia group
Patients in this group receive spinal anesthesia.
 Device: nerve block combined with general anesthesia
Patients in this group receive nerve block combined with general anesthesia.

Device: spinal anesthesia
Patients in this group receive spinal anesthesia.
Placebo Comparator: control group
This group is used to obtain the learning effect.
 Device: nerve block combined with general anesthesia
Patients in this group receive nerve block combined with general anesthesia.

Device: spinal anesthesia
Patients in this group receive spinal anesthesia.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of PND seven days after surgery [ Time Frame: seven days after surgery ]

Secondary Outcome Measures :
  1. Incidence of PND one month after surgery [ Time Frame: one month after surgery ]
  2. Incidence of PND one year after surgery [ Time Frame: one year after surgery ]
  3. Hospital stay [ Time Frame: one to two weeks after surgery ]
  4. Number of patients entrance the ward of ICU after surgery [ Time Frame: one week post-operation ]
  5. Mortality rate [ Time Frame: one year after surgery ]
  6. Postoperative complications [ Time Frame: one month post-operation ]
  7. ADL of frontal lobe，temporal lobe and occipital lobe [ Time Frame: one day pre-operation, one week post-operation ]
  8. ADL of frontal lobe [ Time Frame: one day pre-operation, one week post-operation ]
  9. BOLD of the whole brain [ Time Frame: one day pre-operation, one week post-operation ]
  10. ADL of temporal lobe [ Time Frame: one day pre-operation, one week post-operation ]
  11. ADL of occipital lobe [ Time Frame: one day pre-operation, one week post-operation ]
  12. One year event-free survival [ Time Frame: one year after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488952


Contacts
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Contact: Zhiheng Liu, MD +86-0755-83366388 15818585570@163.com
Contact: Nanbo Luo, MD +86-0755-83366388 316916645@qq.com

Locations
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China, Guangdong
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Nanbo Luo, MD    +8615112389303    316916645@qq.com   
Sponsors and Collaborators
Shenzhen Second People's Hospital
More Information
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Publications:

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Responsible Party: ZhiHeng Liu, Chair of Department of Anesthesiology, Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT04488952    
Other Study ID Numbers: 20193357001-XZ01
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZhiHeng Liu, Shenzhen Second People's Hospital:
PND,anesthesia method, elderly
Additional relevant MeSH terms:
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Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs