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

PND Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488952
• Other study ID #: 20193357001-XZ01
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2022
• Source: Shenzhen Second People's Hospital
• Contact: Zhiheng Liu, MD
• Phone: +86-0755-83366388
• Email: 15818585570[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Neurocognitive Disorders
• PND

Intervention

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

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PND seven days after surgery		seven days after surgery
Secondary	Incidence of PND one month after surgery		one month after surgery
Secondary	Incidence of PND one year after surgery		one year after surgery
Secondary	Hospital stay		one to two weeks after surgery
Secondary	Number of patients entrance the ward of ICU after surgery		one week post-operation
Secondary	Mortality rate		one year after surgery
Secondary	Postoperative complications		one month post-operation
Secondary	ADL of frontal lobe,temporal lobe and occipital lobe		one day pre-operation, one week post-operation
Secondary	ADL of frontal lobe		one day pre-operation, one week post-operation
Secondary	BOLD of the whole brain		one day pre-operation, one week post-operation
Secondary	ADL of temporal lobe		one day pre-operation, one week post-operation
Secondary	ADL of occipital lobe		one day pre-operation, one week post-operation
Secondary	One year event-free survival		one year after surgery