Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty - Full Text View

Purpose

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

Condition	Intervention
Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents	Procedure: non-electroacupuncture Procedure: Electroacupuncture


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

the mean infusion rate of intraoperative remifentanil and propofol [ Time Frame: during operation ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Visual analogue scale [ Time Frame: post-operative 4h, 8h, 24h and 48h ] [ Designated as safety issue: No ]
To assess whether EA pretreatment could help in alleviating acute post-operative pain.
Extubation time [ Time Frame: postoperation ] [ Designated as safety issue: No ]
To investigate the time from the end of propofol and remifentanil infusion to extubation. To assess whether EA pretreatment could shorten the extubation time.

Other Outcome Measures:

plasma β-endorphin and cortisol concentration [ Time Frame: preoperation, 0h and 24h postoperation ] [ Designated as safety issue: No ]
To assess whether EA pretreatment could increase the plasma levels of β-endorphin and cortisol.
Ramsay score [ Time Frame: post-operative 4h, 8h, 24h, 48h ] [ Designated as safety issue: No ]
To assess the effect of EA pretreatment on post-operative Ramsay scores.
incidence of post-operative nausea and vomiting (PONV) [ Time Frame: within post-operative 24 hours ] [ Designated as safety issue: No ]
To assess the effect of EA pretreatment on PONV.


Enrollment:	137
Study Start Date:	June 2012
Study Completion Date:	December 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Sham

Arms

Assigned Interventions

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 Name: Sham

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).

Eligibility


Ages Eligible for Study:	29 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01700855

Locations


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

Sponsors and Collaborators

Xijing Hospital

Investigators


Study Director:	Qiang Wang, M.D., Ph.D.	Xijing Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	wangqiang, Associate Professor, Associate Consultant, Xijing Hospital
ClinicalTrials.gov Identifier:	NCT01700855 History of Changes
Other Study ID Numbers:	mazuike-28
Study First Received:	September 3, 2012
Last Updated:	July 10, 2014
Health Authority:	China: Food and Drug Administration

Keywords provided by Xijing Hospital:


Electroacupuncture Analgesia Anesthesia Nasal septoplasty Mammaplasty

ClinicalTrials.gov processed this record on September 30, 2016