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

Not Applicable

• Conditions: Acupuncture
• Interventions: Device: TEAS

• Registration Number: NCT02597530
• Lead Sponsor: wangqiang

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-10-29
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-term stimulution group	TEAS	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.
Sham group	TEAS	Patients in sham group will be pasted electrodes 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.
Short-term stimulution group	TEAS	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.

Primary Outcome Measures

Name	Time	Method
Consumption of remifentanil during the operation（ug/kg/min）.	intraoperative

Secondary Outcome Measures

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