Transcutaneous Electrical Stimulation of the Vagus Nerve

RenJi Hospital110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

110

Conditions

Cognitive Dysfunction

Interventions

transcutaneous vagus nerve electric stimulatorDEVICE

The stimulator that can be attached to ears of the patient.We suppose that this device can reduce the incidence of perioperative neurocognitive disorders(PND)

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Diansan Su

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Incidence of perioperative neurocognitive disorders

make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.

Time frame: one month

Central Contacts

Diansan Su

CONTACT

+862168383702 diansansu@yahoo.com

Yichen Fan

CONTACT

+86 13482827569 mcking95@126.com

Data from ClinicalTrials.gov

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