Neurohumoral Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS)

November 19, 2015 updated by: wangqiang

Neurohumor Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS): A Prospective, Randomized Controlled Trial

The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients were randomly assigned to three groups, receiving TEAS 30min before anesthesia. The frequency of high frequency group is set to 10/50HZ, low frequency group is 2/10HZ, and the fake stimulation group only attach electrodes without electric current. Acupoint selection is bilateral Neiguan points(PC6). Venous blood is collected 4ml before and immediately after TEAS respectively. Heart rate variability is monitored continuously during the 30min TEAS. The adverse events recorded.

Study Type

Interventional

Enrollment (Anticipated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18yrs-65yrs
  • ASA 1-2
  • Scheduled for elective operation under general anesthesia
  • BMI 18-30kg/m2
  • Informed consented

Exclusion Criteria:

  • Contraindications to TEAS
  • Communication difficulty with researchers
  • Addicted to alcohol, analgesics or other drugs
  • Cardiac insufficiency or high blood pressure without controlled
  • Hepatic or renal dysfunction
  • Participate in the other clinical trial 3 month before the enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2/10HZ TEAS pretreatment
Patients were given 30min of 2/10HZ TEAS before anesthesia
Device: TEAS (transcutaneous electrical acupoint stimulation)
2/10HZ Electric stimulation was given through electrode attached to specific acupoints
Device: TEAS (transcutaneous electrical acupoint stimulation)
10/50HZ Electric stimulation was given through electrode attached to specific acupoints
Experimental: 10/50HZ TEAS pretreatment
Patients were given 30min of 10/50HZ TEAS before anesthesia
Device: TEAS (transcutaneous electrical acupoint stimulation)
2/10HZ Electric stimulation was given through electrode attached to specific acupoints
Device: TEAS (transcutaneous electrical acupoint stimulation)
10/50HZ Electric stimulation was given through electrode attached to specific acupoints
Sham Comparator: fake stimulation
Patients were only attached electrodes without electric current
Device: fake stimulation
Patients were only attached electrodes without electric current

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of epinephrine(ng/L)
Time Frame: change of TEAS 0 and 30 minutes
change of TEAS 0 and 30 minutes
Plasma concentration of norepinephrine(ng/L)
Time Frame: change of TEAS 0 and 30 minutes
change of TEAS 0 and 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate variability
Time Frame: During 30min TEAS
During 30min TEAS
plasma concentration of glucocorticoid(μg/L)
Time Frame: change of TEAS 0 and 30 minutes
change of TEAS 0 and 30 minutes
plasma concentration of aldosterone(ng/L)
Time Frame: change of TEAS 0 and 30 minutes
change of TEAS 0 and 30 minutes
plasma concentration of renin(ng/L)
Time Frame: change of TEAS 0 and 30 minutes
change of TEAS 0 and 30 minutes
plasma concentration of β-endorphin(ng/L)
Time Frame: change of TEAS 0 and 30 minutes
change of TEAS 0 and 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

wangqiang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 15, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2015-10-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypotension

Clinical Trials on TEAS (transcutaneous electrical acupoint stimulation)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe