Different Stimuli of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia (TEAS)

December 10, 2015 updated by: wangqiang

Effect of Different Time of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia

To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases by Jingluo (the system of meridians, through which energy is thought to flow through the body in Chinese medicine). It is usually applied to relieve pain. Several clinical trials have been conducted to evaluate the effect of electroacupuncture on the consumption of intra-operative anaesthetics and on drug-related side-effects, with promising results. Compared with acupuncture or electroacupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique and has some advantages, including no risk of infections or needle-induced contagious disease and reduced fear of stimulation. It can potentially be applied by any anaesthetist or pre-operative personnel with minimal training.Thus, investigators conducted this controlled, prospective, double-blinded clinical trial to investigate whether treating by transcutaneous electrical acupoint stimulation combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

Study Type

Interventional

Enrollment (Anticipated)

60

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

Study Contact Backup

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged between 18 and 65
  2. ASA physical statusⅠorⅡ
  3. Elective gynecological laparoscopic surgery under general anesthesia
  4. BMI of 18 to 25
  5. Duration of operation≤2 hours
  6. Patient who signed the informed consent

Exclusion Criteria:

  1. Pregnancy or breast-feeding women
  2. Serious lung disease/Serious cardiovascular disease/Serious liver, renal abnormalities
  3. Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease
  4. Patient has diseases in nervous-mental system
  5. Operation time more than 2 hours
  6. Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints;
  7. Patients with experience of transcutaneous electrical stimulation treatment.

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-term stimulution group
According to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.Patients in Long-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and continued until the end of the surgery with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over.
Device: TEAS
According to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.
Other: Short-term stimulution group
According to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.The patients in Short-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over.
Device: TEAS
According to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.
Placebo Comparator: Sham group
Patients in sham group will be pasted electrodes 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.
Device: TEAS
According to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of remifentanil during the operation（ug/kg/min）.
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),β-endorphin(ng/mL) and glucose(mmol/L)).
Time Frame: intraoperative
intraoperative
Time of extubation after operation.
Time Frame: intraoperative
intraoperative
Pain after the operation(visual analog scale (vas)).
Time Frame: 0 hours ,2 hours ,12 hours ,24 hours after operation
0 hours ,2 hours ,12 hours ,24 hours after operation
Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).
Time Frame: 0 hours ,2 hours ,12 hours ,24 hours after operation
0 hours ,2 hours ,12 hours ,24 hours after operation
Hospital stays after operation(d).
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Participants will be followed for the duration of hospital stay, an expected average of 4 days

Collaborators and Investigators

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

Sponsor

wangqiang

Investigators

  • Study Chair: Qiang x Qiang Wang, Xijing Hospital

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

November 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Xijingmazui
  • mazuike (Other Identifier: Xijing Hospital)

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 Acupuncture

Clinical Trials on TEAS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe