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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
Sponsor:
Information provided by (Responsible Party):
wangqiang, Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents Procedure: non-electroacupuncture Procedure: Electroacupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. Ramsay score [ Time Frame: post-operative 4h, 8h, 24h, 48h ]
    To assess the effect of EA pretreatment on post-operative Ramsay scores.

  3. incidence of post-operative nausea and vomiting (PONV) [ Time Frame: within post-operative 24 hours ]
    To assess the effect of EA pretreatment on PONV.


Eligibility Criteria
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Ages Eligible for Study:   29 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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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


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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: wangqiang, Associate Professor, Associate Consultant, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01700855     History of Changes
Other Study ID Numbers: mazuike-28
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: May 2012

Keywords provided by wangqiang, Xijing Hospital:
Electroacupuncture
Analgesia
Anesthesia
Nasal septoplasty
Mammaplasty