Transcutaneous Electrical Stimulation of the Vagus Nerve (TESVNR)

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Cognitive Dysfunction

Treatments: Device: transcutaneous vagus nerve electric stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT03989375

diansansu2018013

Details and patient eligibility

About

This study evaluate the cognitive functions of patient after hip or kneel replacement.Half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy

Enrollment: 110 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• over 65 years old
• ability to communication
• hip or kneel replacement
• willing to participate in the study
• ASA I-II

Exclusion criteria

• with cerebral disorders or disease
• cognitive impairment before surgery
• with mental disease
• unable to communication
• severe eyes or ears impairment
• surgery performed in the past 30 days
• Bradycardia，II°AVB，III°AVB，severe heart, liver and kidney dysfunction
• severe skin disease
• refuse to enter the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

experiment group

Experimental group

Treatment:

Device: transcutaneous vagus nerve electric stimulator

control group

No Intervention group