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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

Tracking Information
First Submitted Date  ICMJE September 3, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date July 11, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
the mean infusion rate of intraoperative remifentanil and propofol [ Time Frame: from the beginning to the end of infusion ]
To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2012)
  • 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: from the end of propofol and remifentanil infusion to extubation ]
    To assess whether EA pretreatment could shorten the extubation time.
Current Other Pre-specified Outcome Measures
 (submitted: October 7, 2012)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: October 1, 2012)
  • plasma β-endorphin and cortisol concentration [ Time Frame: before EA pretreatment, when incisions are closed, and 24h after operation ]
    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.
 
Descriptive Information
Brief Title  ICMJE Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
Official Title  ICMJE Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
Intervention  ICMJE
  • Procedure: non-electroacupuncture
    The same procedure as electroacupuncture except stimulation
    Other Name: Sham
  • 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
Study Arms  ICMJE
  • Experimental: Electroacupuncture
    Patients received electroacupuncture stimulation
    Intervention: Procedure: Electroacupuncture
  • Sham Comparator: Non-electroacupuncture
    Patients received sham electroacupuncture
    Intervention: Procedure: non-electroacupuncture
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
137
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2012)
60
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 29 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700855
Other Study ID Numbers  ICMJE mazuike-28
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party wangqiang, Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Qiang Wang, M.D., Ph.D. Xijing Hospital
PRS Account Xijing Hospital
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP