Clinical trial NCT02850471: 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
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Reperfusion Injury
Keywords: Postoperative pulmonary complications
Transcutaneous electric acupoint stimulation
pulmonary protection
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: the change of hemodynamic parameter MAP in mmHg
timeFrame: intraoperative
measure: the change of hemodynamic parameters HR in beat per minutes
timeFrame: intraoperative
measure: the change of blood SPO2 in percentage
timeFrame: intraoperative
measure: the change of blood pH
timeFrame: intraoperative
measure: the change of blood PCO2 in mmHg
timeFrame: intraoperative
measure: the change of blood PO2 in mmHg
timeFrame: intraoperative
Secondary outcomes:
measure: the change of Plasma concentration of TNF-α in pg/mL
timeFrame: intraoperative
measure: post-operative pulmonary complications
timeFrame: in the first 5 days after surgery
measure: the change of plasma concentration of IL-1β
timeFrame: intraoperative
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China medical university
state: Liaoning
Study officials:
affiliation: professor
name: Junchao Zhu, doctor
role: STUDY_DIRECTOR
References:
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.