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Completed

NCT Number: NCT01700855

Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

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

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Key information

Conditions

Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

29 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-electroacupuncture

Procedure

The same procedure as electroacupuncture except stimulation

Other names: Sham

electroacupuncture

Procedure

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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