Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type DEVICE

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.

controlled group

Patients in controlled group treated without TEAS or other placebo.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electroacupuncture

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes