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

April 26, 2022 updated by: ZhiHeng Liu, Shenzhen Second People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of PND seven days after surgery
Time Frame: seven days after surgery
seven days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Second People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20193357001-XZ01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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