Transcutaneous Electrical Stimulation of the Vagus Nerve

Not Applicable

Not yet recruiting

• Conditions: Cognitive Dysfunction
• Interventions: Device: transcutaneous vagus nerve electric stimulator

• Registration Number: NCT03989375
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-16
• Study First Submitted QC: 2019-06-16
• Last Update Submitted: 2019-06-16
• Study First Posted: 2019-06-18
• Last Update Posted: 2019-06-18
• Study Start: 2019-07-01
• Primary Completion: 2020-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experiment group	transcutaneous vagus nerve electric stimulator	-

Primary Outcome Measures

Name	Time	Method
Incidence of perioperative neurocognitive disorders	one month	make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.

Trial Locations

Locations (1)

Diansan Su; 🇨🇳 Shanghai, Shanghai, China