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

NCT ID: NCT04488952

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2024-06-01

Brief Summary

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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

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Conditions

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PND

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nerve block combined with general anesthesia group

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

Group Type EXPERIMENTAL

nerve block combined with general anesthesia

Intervention Type DEVICE

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

spinal anesthesia

Intervention Type DEVICE

Patients in this group receive spinal anesthesia.

spinal anesthesia group

Patients in this group receive spinal anesthesia.

Group Type EXPERIMENTAL

nerve block combined with general anesthesia

Intervention Type DEVICE

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

spinal anesthesia

Intervention Type DEVICE

Patients in this group receive spinal anesthesia.

control group

This group is used to obtain the learning effect.

Group Type PLACEBO_COMPARATOR

nerve block combined with general anesthesia

Intervention Type DEVICE

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

spinal anesthesia

Intervention Type DEVICE

Patients in this group receive spinal anesthesia.

Interventions

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nerve block combined with general anesthesia

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

Intervention Type DEVICE

spinal anesthesia

Patients in this group receive spinal anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen Second People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZhiHeng Liu

Chair of Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiheng Liu, MD

Role: CONTACT

+86-0755-83366388

Nanbo Luo, MD

Role: CONTACT

+86-0755-83366388

Facility Contacts

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Nanbo Luo, MD

Role: primary

+8615112389303

References

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Other Identifiers

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20193357001-XZ01

Identifier Type: -

Identifier Source: org_study_id

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