Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

NCT ID: NCT01700855

Last Updated: 2014-07-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.

Detailed Description

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Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc).

Conditions

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Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Electroacupuncture

Patients received electroacupuncture stimulation

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type PROCEDURE

Electrodes are applied to bilateral "Hegu(L14)" acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3\~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.

Non-electroacupuncture

Patients received sham electroacupuncture

Group Type SHAM_COMPARATOR

non-electroacupuncture

Intervention Type PROCEDURE

The same procedure as electroacupuncture except stimulation

Interventions

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non-electroacupuncture

The same procedure as electroacupuncture except stimulation

Intervention Type PROCEDURE

Electroacupuncture

Electrodes are applied to bilateral "Hegu(L14)" acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3\~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.

Intervention Type PROCEDURE

Other Intervention Names

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Sham Electroacupuncture preconditioning Electroacupuncture pretreatment Transcutaneous electric nerve stimulation

Eligibility Criteria

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Inclusion Criteria

* selective nasal sinus surgery
* selective mammaplasty
* patients who accept the follow-up and sign the informed consent
* ASA 1\~2

Exclusion Criteria

* emergent surgery
* pregnant or breast-feeding women
* coagulopathy
* history of gastrointestinal ulcer
* liver or renal dysfunction
* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
Minimum Eligible Age

29 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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wangqiang

Associate Professor, Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Wang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

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 DERIVED
PMID: 24576720 (View on PubMed)

Other Identifiers

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mazuike-28

Identifier Type: -

Identifier Source: org_study_id

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