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SuspendedNCT02850471Updated Aug 1, 2016

Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

A Phase 1/2 interventional study of electroacupuncture in Reperfusion Injury, sponsored by Shengjing Hospital. Suspended at 1 site in China. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-01.

Sponsored by Shengjing Hospital · Phase 1/2, Interventional, and Prevention

Why this study was suspended
we need more participants to complete the research
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
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Study summary

TEAS might protect against postoperative pulmonary such as ischemia-reperfusion injury (IRI) and atelectasis. We tested the hypothesis that transcutaneous electrical acupoint stimulation protects against postoperative pulmonary complications in patients who are receiving mechanical ventilation during general anesthesia for gynecologic laparoscopic surgery.

Read the detailed description

Participants: 100 patients who underwent elective gynecologic laparoscopic surgery Methods: We recruited 100 patients who are planned for gynecologic laparoscopic surgery. Patients were enrolled from March 1, 2015. We randomly allocated patients into two groups: controlled group ( patients treated without transcutaneous electrical acupoint stimulation) and TEAS group (patients treated with TEAS on Feishu, Hegu, Chize half an hour before the surgery). Blood pH, Pco2, Po2 and oxygen saturation were measured by an automatic blood gas analyzer immediately after obtaining the samples from the aorta. Sample all the patients blood before and after the surgery. And then measure the level of TNF-α, IL-1β, and IL-6.

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Conditions studied

  • Reperfusion Injury

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Keywords

  • Postoperative pulmonary complications
  • Transcutaneous electric acupoint stimulation
  • pulmonary protection
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In context

Reperfusion Injury

271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.

This study's planned enrollment of 100 is above the median of 61 across 215 interventional studies indexed under Reperfusion Injury.

Browse Reperfusion Injury studies →

Lead sponsor

Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged from 65 to 75
  • The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ \~ III
  • scheduled for gynecologic laparoscopic surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • pre-existing lung or caridac disease
  • impaired kidney or liver function
  • history of bronchial asthma or chronic obstructive pulmonary disease
  • history of smoking
  • respiratory infection in the previous 2 weeks
  • preoperative use of bronchodilator, or a steroid
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    TEAS group

    Before anesthesia, patients in this group treated with Transcutaneous Electric Acupoint Stimulation (TEAS) which is an electroacupuncture on Feishu, Hegu, Chize half an hour before the surgery, using the device Hua Tuo SDZ-II Acupoint Stimulator. The stimulus parameters set as 2/100Hz, 2V, 30min.

    Device: electroacupuncture

  • No intervention
    controlled group

    Patients in controlled group treated without TEAS or other placebo.

Interventions

  • Deviceelectroacupuncture

    Transcutaneous Electric Acupoint Stimulation which is a device of electroacupuncture was used on patients in TEAS group with the stimulator parameters set as 2/100Hz, 2V, 30min.

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What researchers measure

Primary outcomes

  1. the change of hemodynamic parameter MAP in mmHg

    Time frame: intraoperative

  2. the change of hemodynamic parameters HR in beat per minutes

    Time frame: intraoperative

  3. the change of blood SPO2 in percentage

    Time frame: intraoperative

  4. the change of blood pH

    Time frame: intraoperative

  5. the change of blood PCO2 in mmHg

    Time frame: intraoperative

  6. the change of blood PO2 in mmHg

    Time frame: intraoperative

Secondary outcomes

  1. the change of Plasma concentration of TNF-α in pg/mL

    Time frame: intraoperative

  2. post-operative pulmonary complications

    Time frame: in the first 5 days after surgery

  3. the change of plasma concentration of IL-1β

    Time frame: intraoperative

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Study locations

1 site
  • Shengjing hospital of China medical university
    Shenyang, Liaoning 110000, China
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References and documents

Publications

  • Wei W, Bai W, Yang Y, Li Y, Teng X, Wan Y, Zhu J. Pulmonary protection of transcutaneous electrical acupoint stimulation in gynecological laparoscopic surgery: A randomized controlled trial. Exp Ther Med. 2020 Jan;19(1):511-518. doi: 10.3892/etm.2019.8245. Epub 2019 Nov 26. PubMed 31885697 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02850471
Lead sponsor
Shengjing Hospital
Responsible party
Yanchao Yang (resident doctor, Shengjing Hospital) — Principal investigator
First posted
Aug 1, 2016
Start date
Mar 2015
Primary completion
Dec 2015
Completion
Aug 2016 (estimated)
Last update
Aug 1, 2016

Study contacts

Junchao Zhu, doctor
study director · professor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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