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

NCT ID: NCT02597530

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Acupuncture

Keywords

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TEAS anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

TEAS

Intervention Type DEVICE

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.

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.

Group Type OTHER

TEAS

Intervention Type DEVICE

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.

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.

Group Type PLACEBO_COMPARATOR

TEAS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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wangqiang

OTHER

Sponsor Role lead

Responsible Party

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wangqiang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qiang x Qiang Wang

Role: STUDY_CHAIR

Xijing Hospital

Central Contacts

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Shan He

Role: CONTACT

Phone: 15129014406

Email: [email protected]

Qiang Wang

Role: CONTACT

Phone: 86-29-84775343

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24576720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25456960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24447388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22096284 (View on PubMed)

Han JS. Acupuncture analgesia: areas of consensus and controversy. Pain. 2011 Mar;152(3 Suppl):S41-S48. doi: 10.1016/j.pain.2010.10.012. No abstract available.

Reference Type BACKGROUND
PMID: 21078546 (View on PubMed)

Other Identifiers

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mazuike

Identifier Type: OTHER

Identifier Source: secondary_id

Xijingmazui

Identifier Type: -

Identifier Source: org_study_id