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

September 3, 2012
July 10, 2014
June 2012
November 2012   (final data collection date for primary outcome measure)
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.
the mean infusion rate of intraoperative remifentanil and propofol [ Time Frame: from the beginning to the end of infusion ] [ Designated as safety issue: No ]
To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
Complete list of historical versions of study NCT01700855 on ClinicalTrials.gov Archive Site
  • 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.
  • 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: from the end of propofol and remifentanil infusion to extubation ] [ Designated as safety issue: No ]
    To assess whether EA pretreatment could shorten the extubation time.
  • 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.
  • plasma β-endorphin and cortisol concentration [ Time Frame: before EA pretreatment, when incisions are closed, and 24h after operation ] [ 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.
 
Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study

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

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
  • 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
  • Experimental: Electroacupuncture
    Patients received electroacupuncture stimulation
    Intervention: Procedure: Electroacupuncture
  • Sham Comparator: Non-electroacupuncture
    Patients received sham electroacupuncture
    Intervention: Procedure: non-electroacupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
29 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01700855
mazuike-28
Yes
wangqiang, Xijing Hospital
Xijing Hospital
Not Provided
Study Director: Qiang Wang, M.D., Ph.D. Xijing Hospital
Xijing Hospital
May 2012

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