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

Primary Purpose

PND

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nerve block combined with general anesthesia
spinal anesthesia
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PND focused on measuring PND,anesthesia method, elderly

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Shenzhen Second People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

nerve block combined with general anesthesia group

spinal anesthesia group

control group

Arm Description

Patients in this group receive nerve block combined with general anesthesia.

Patients in this group receive spinal anesthesia.

This group is used to obtain the learning effect.

Outcomes

Primary Outcome Measures

Incidence of PND seven days after surgery

Secondary Outcome Measures

Incidence of PND one month after surgery
Incidence of PND one year after surgery
Hospital stay
Number of patients entrance the ward of ICU after surgery
Mortality rate
Postoperative complications
ADL of frontal lobe,temporal lobe and occipital lobe
ADL of frontal lobe
BOLD of the whole brain
ADL of temporal lobe
ADL of occipital lobe
One year event-free survival

Full Information

First Posted
July 22, 2020
Last Updated
April 26, 2022
Sponsor
Shenzhen Second People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04488952
Brief Title
The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly
Official Title
The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Second People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PND
Keywords
PND,anesthesia method, elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nerve block combined with general anesthesia group
Arm Type
Experimental
Arm Description
Patients in this group receive nerve block combined with general anesthesia.
Arm Title
spinal anesthesia group
Arm Type
Experimental
Arm Description
Patients in this group receive spinal anesthesia.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
This group is used to obtain the learning effect.
Intervention Type
Device
Intervention Name(s)
nerve block combined with general anesthesia
Intervention Description
Patients in this group receive nerve block combined with general anesthesia.
Intervention Type
Device
Intervention Name(s)
spinal anesthesia
Intervention Description
Patients in this group receive spinal anesthesia.
Primary Outcome Measure Information:
Title
Incidence of PND seven days after surgery
Time Frame
seven days after surgery
Secondary Outcome Measure Information:
Title
Incidence of PND one month after surgery
Time Frame
one month after surgery
Title
Incidence of PND one year after surgery
Time Frame
one year after surgery
Title
Hospital stay
Time Frame
one to two weeks after surgery
Title
Number of patients entrance the ward of ICU after surgery
Time Frame
one week post-operation
Title
Mortality rate
Time Frame
one year after surgery
Title
Postoperative complications
Time Frame
one month post-operation
Title
ADL of frontal lobe,temporal lobe and occipital lobe
Time Frame
one day pre-operation, one week post-operation
Title
ADL of frontal lobe
Time Frame
one day pre-operation, one week post-operation
Title
BOLD of the whole brain
Time Frame
one day pre-operation, one week post-operation
Title
ADL of temporal lobe
Time Frame
one day pre-operation, one week post-operation
Title
ADL of occipital lobe
Time Frame
one day pre-operation, one week post-operation
Title
One year event-free survival
Time Frame
one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiheng Liu, MD
Phone
+86-0755-83366388
Email
15818585570@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nanbo Luo, MD
Phone
+86-0755-83366388
Email
316916645@qq.com
Facility Information:
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanbo Luo, MD
Phone
+8615112389303
Email
316916645@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly

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