Clinical trial NCT01700855: Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
Official title: Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
Keywords: Electroacupuncture
Analgesia
Anesthesia
Nasal septoplasty
Mammaplasty
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 137
Sex: ALL
Minimum age (years): 29
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: the mean infusion rate of intraoperative remifentanil and propofol
timeFrame: during operation
Secondary outcomes:
measure: Visual analogue scale
timeFrame: post-operative 4h, 8h, 24h and 48h
measure: Extubation time
timeFrame: postoperation
Other outcomes:
measure: plasma β-endorphin and cortisol concentration
timeFrame: preoperation, 0h and 24h postoperation
measure: Ramsay score
timeFrame: post-operative 4h, 8h, 24h, 48h
measure: incidence of post-operative nausea and vomiting (PONV)
timeFrame: within post-operative 24 hours
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Qiang Wang, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.