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Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
wangqiang, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01700855
First received: September 3, 2012
Last updated: July 10, 2014
Last verified: May 2012
History of Changes
  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:

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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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 February 27, 2015