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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

Tracking Information
First Submitted Date  ICMJE July 22, 2020
First Posted Date  ICMJE July 28, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE July 8, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)		 Incidence of PND seven days after surgery [ Time Frame: seven days after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • Incidence of PND one month after surgery [ Time Frame: one month after surgery ]
  • Incidence of PND one year after surgery [ Time Frame: one year after surgery ]
  • Hospital stay [ Time Frame: one to two weeks after surgery ]
  • Number of patients entrance the ward of ICU after surgery [ Time Frame: one week post-operation ]
  • Mortality rate [ Time Frame: one year after surgery ]
  • Postoperative complications [ Time Frame: one month post-operation ]
  • ADL of frontal lobe，temporal lobe and occipital lobe [ Time Frame: one day pre-operation, one week post-operation ]
  • ADL of frontal lobe [ Time Frame: one day pre-operation, one week post-operation ]
  • BOLD of the whole brain [ Time Frame: one day pre-operation, one week post-operation ]
  • ADL of temporal lobe [ Time Frame: one day pre-operation, one week post-operation ]
  • ADL of occipital lobe [ Time Frame: one day pre-operation, one week post-operation ]
  • One year event-free survival [ Time Frame: one year after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly
Official Title  ICMJE The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE PND
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: nerve block combined with general anesthesia group
    Patients in this group receive nerve block combined with general anesthesia.
    Interventions:
    • Device: nerve block combined with general anesthesia
    • Device: spinal anesthesia
  • Experimental: spinal anesthesia group
    Patients in this group receive spinal anesthesia.
    Interventions:
    • Device: nerve block combined with general anesthesia
    • Device: spinal anesthesia
  • Placebo Comparator: control group
    This group is used to obtain the learning effect.
    Interventions:
    • Device: nerve block combined with general anesthesia
    • Device: spinal anesthesia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2020)		 350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zhiheng Liu, MD +86-0755-83366388 15818585570@163.com
Contact: Nanbo Luo, MD +86-0755-83366388 316916645@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04488952
Other Study ID Numbers  ICMJE 20193357001-XZ01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ZhiHeng Liu, Shenzhen Second People's Hospital
Study Sponsor  ICMJE Shenzhen Second People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenzhen Second People's Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP