Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Study Overview
=================
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.

Official Title
-----------------
Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Conditions
-----------------
Reperfusion Injury

Intervention / Treatment
-----------------
* Device: electroacupuncture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS group<br>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<br>* 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.<br>|
| No Intervention: controlled group<br>Patients in controlled group treated without TEAS or other placebo. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of hemodynamic parameter MAP in mmHg |  | intraoperative | 
| the change of hemodynamic parameters HR in beat per minutes |  | intraoperative | 
| the change of blood SPO2 in percentage |  | intraoperative | 
| the change of blood pH |  | intraoperative | 
| the change of blood PCO2 in mmHg |  | intraoperative | 
| the change of blood PO2 in mmHg |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of Plasma concentration of TNF-α in pg/mL |  | intraoperative | 
| post-operative pulmonary complications |  | in the first 5 days after surgery | 
| the change of plasma concentration of IL-1β |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pulmonary complications, Transcutaneous electric acupoint stimulation, pulmonary protection