NCT03989375

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 16, 2019

Last Update Submit

June 16, 2019

Conditions

Cognitive Dysfunction

Keywords

postoperative Cognitive Dysfunctionhip- and knee arthroplastytranscutaneous vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Incidence of perioperative neurocognitive disorders

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

    one month

Study Arms (2)

experiment group

EXPERIMENTAL
Device: transcutaneous vagus nerve electric stimulator

control group

NO INTERVENTION

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)

experiment group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diansan Su

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Cognitive DysfunctionPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Diansan Su

CONTACT

+862168383702diansansu@yahoo.com

Yichen Fan

CONTACT

+86 13482827569mcking95@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professer

Study Record Dates

First Submitted

June 16, 2019

First Posted

June 18, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2025

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

CN(1)