Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
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|ClinicalTrials.gov Identifier: NCT01700855|
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : July 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents||Procedure: non-electroacupuncture Procedure: Electroacupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2012|
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
- 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.
- 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.
- 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.
- 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.
- Ramsay score [ Time Frame: post-operative 4h, 8h, 24h, 48h ]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 ]To assess the effect of EA pretreatment on PONV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700855
|Xi'an, Shaanxi, China, 710032|
|Study Director:||Qiang Wang, M.D., Ph.D.||Xijing Hospital|