Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

Not Applicable

Completed

• Conditions: Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
• Interventions: Procedure: Electroacupuncture; Procedure: non-electroacupuncture

• Registration Number: NCT01700855
• Lead Sponsor: Xijing Hospital

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).

Study Timeline

• Status Verified: 2012-05
• Study Start: 2012-06
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-04
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	Electroacupuncture	Patients received electroacupuncture stimulation
Non-electroacupuncture	non-electroacupuncture	Patients received sham electroacupuncture

Primary Outcome Measures

Name	Time	Method
the mean infusion rate of intraoperative remifentanil and propofol	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.

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale	post-operative 4h, 8h, 24h and 48h	To assess whether EA pretreatment could help in alleviating acute post-operative pain.
Extubation time	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China