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

Acupuncture Clinical Trial

— TEAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02597530
• Other study ID #: Xijingmazui
• Secondary ID: mazuike
• Status: Not yet recruiting
• Phase: N/A
• First received: October 29, 2015
• Last updated: December 10, 2015
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: Shan He
• Phone: 15129014406
• Email: 986994820[@]qq.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 65

2. ASA physical status?or?

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acupuncture

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
wangqiang

References & Publications (5)

Han JS. Acupuncture analgesia: areas of consensus and controversy. Pain. 2011 Mar;152(3 Suppl):S41-8. doi: 10.1016/j.pain.2010.10.012. Review. — View Citation

Iacobone M, Citton M, Zanella S, Scarpa M, Pagura G, Tropea S, Galligioni H, Ceccherelli F, Feltracco P, Viel G, Nitti D. The effects of acupuncture after thyroid surgery: A randomized, controlled trial. Surgery. 2014 Dec;156(6):1605-12; discussion 1612-3. doi: 10.1016/j.surg.2014.08.062. Epub 2014 Nov 11. — View Citation

Lee MS, Ernst E. Acupuncture for surgical conditions: an overview of systematic reviews. Int J Clin Pract. 2014 Jun;68(6):783-9. doi: 10.1111/ijcp.12372. Epub 2014 Jan 22. — View Citation

Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):500-5. doi: 10.4103/0970-9185.86595. — View Citation

Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of remifentanil during the operation(ug/kg/min).		intraoperative	No
Secondary	Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),ß-endorphin(ng/mL) and glucose(mmol/L)).		intraoperative	No
Secondary	Time of extubation after operation.		intraoperative	No
Secondary	Pain after the operation(visual analog scale (vas)).		0 hours ,2 hours ,12 hours ,24 hours after operation	No
Secondary	Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).		0 hours ,2 hours ,12 hours ,24 hours after operation	No
Secondary	Hospital stays after operation(d).		Participants will be followed for the duration of hospital stay, an expected average of 4 days	No