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Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Primary Purpose

Reperfusion Injury

Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reperfusion Injury focused on measuring Postoperative pulmonary complications, Transcutaneous electric acupoint stimulation, pulmonary protection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • Shengjing hospital of China medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TEAS group

controlled group

Arm Description

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.

Patients in controlled group treated without TEAS or other placebo.

Outcomes

Primary Outcome Measures

the change of hemodynamic parameter MAP in mmHg
the change of hemodynamic parameters HR in beat per minutes
the change of blood SPO2 in percentage
the change of blood pH
the change of blood PCO2 in mmHg
the change of blood PO2 in mmHg

Secondary Outcome Measures

the change of Plasma concentration of TNF-α in pg/mL
post-operative pulmonary complications
the change of plasma concentration of IL-1β

Full Information

First Posted
July 21, 2016
Last Updated
July 29, 2016
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02850471
Brief Title
Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery
Official Title
Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Suspended
Why Stopped
we need more participants to complete the research
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury
Keywords
Postoperative pulmonary complications, Transcutaneous electric acupoint stimulation, pulmonary protection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAS group
Arm Type
Experimental
Arm Description
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.
Arm Title
controlled group
Arm Type
No Intervention
Arm Description
Patients in controlled group treated without TEAS or other placebo.
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of hemodynamic parameter MAP in mmHg
Time Frame
intraoperative
Title
the change of hemodynamic parameters HR in beat per minutes
Time Frame
intraoperative
Title
the change of blood SPO2 in percentage
Time Frame
intraoperative
Title
the change of blood pH
Time Frame
intraoperative
Title
the change of blood PCO2 in mmHg
Time Frame
intraoperative
Title
the change of blood PO2 in mmHg
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
the change of Plasma concentration of TNF-α in pg/mL
Time Frame
intraoperative
Title
post-operative pulmonary complications
Time Frame
in the first 5 days after surgery
Title
the change of plasma concentration of IL-1β
Time Frame
intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junchao Zhu, doctor
Organizational Affiliation
professor
Official's Role
Study Director
Facility Information:
Facility Name
Shengjing hospital of China medical university
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31885697
Citation
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.
Results Reference
derived

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Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

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