Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

Study Overview
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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).

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

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

Intervention / Treatment
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* Procedure: non-electroacupuncture
* Procedure: Electroacupuncture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br>Patients received electroacupuncture stimulation | Procedure: Electroacupuncture<br>* 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.<br>* Other names: Transcutaneous electric nerve stimulation;|
| Sham Comparator: Non-electroacupuncture<br>Patients received sham electroacupuncture | Procedure: non-electroacupuncture<br>* The same procedure as electroacupuncture except stimulation<br>* Other names: Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean infusion rate of intraoperative remifentanil and propofol | 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 | To assess whether EA pretreatment could help in alleviating acute post-operative pain. | post-operative 4h, 8h, 24h and 48h | 
| Extubation time | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Electroacupuncture, Anesthesia, Nasal septoplasty, Mammaplasty