Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

July 10, 2014 updated by: wangqiang, Xijing Hospital

Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

137

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

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

29 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture
Patients received electroacupuncture stimulation
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.
Other Names:
  • Electroacupuncture preconditioning
  • Electroacupuncture pretreatment
  • Transcutaneous electric nerve stimulation
Sham Comparator: Non-electroacupuncture
Patients received sham electroacupuncture
Procedure: non-electroacupuncture
The same procedure as electroacupuncture except stimulation
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean infusion rate of intraoperative remifentanil and propofol
Time Frame: during operation
To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
during operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: post-operative 4h, 8h, 24h and 48h
To assess whether EA pretreatment could help in alleviating acute post-operative pain.
post-operative 4h, 8h, 24h and 48h
Extubation time
Time Frame: postoperation
To investigate the time from the end of propofol and remifentanil infusion to extubation. To assess whether EA pretreatment could shorten the extubation time.
postoperation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma β-endorphin and cortisol concentration
Time Frame: preoperation, 0h and 24h postoperation
To assess whether EA pretreatment could increase the plasma levels of β-endorphin and cortisol.
preoperation, 0h and 24h postoperation
Ramsay score
Time Frame: post-operative 4h, 8h, 24h, 48h
To assess the effect of EA pretreatment on post-operative Ramsay scores.
post-operative 4h, 8h, 24h, 48h
incidence of post-operative nausea and vomiting (PONV)
Time Frame: within post-operative 24 hours
To assess the effect of EA pretreatment on PONV.
within post-operative 24 hours

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Study Director: Qiang Wang, M.D., Ph.D., 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

June 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • mazuike-28

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.

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