Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Phase 1

Suspended

• Conditions: Reperfusion Injury
• Interventions: Device: electroacupuncture

• Registration Number: NCT02850471
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Study Completion: 2016-08
• Study First Posted: 2016-08-01
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEAS group	electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
the change of blood pH	intraoperative
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 PCO2 in mmHg	intraoperative
the change of blood PO2 in mmHg	intraoperative

Secondary Outcome Measures

Name	Time	Method
post-operative pulmonary complications	in the first 5 days after surgery
the change of Plasma concentration of TNF-α in pg/mL	intraoperative
the change of plasma concentration of IL-1β	intraoperative

Trial Locations

Locations (1)

Shengjing hospital of China medical university; 🇨🇳 Shenyang, Liaoning, China