Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.
Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
|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|
- 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.
- 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.
- 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.
|Study Start Date:||June 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Patients received electroacupuncture stimulation
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.
Sham Comparator: Non-electroacupuncture
Patients received sham electroacupuncture
The same procedure as electroacupuncture except stimulation
Other Name: Sham
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700855
|Xi'an, Shaanxi, China, 710032|
|Study Director:||Qiang Wang, M.D., Ph.D.||Xijing Hospital|