Reperfusion Injury Clinical Trial
Official title:
Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery
Verified date | July 2016 |
Source | Shengjing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 100 |
Est. completion date | August 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Aged from 65 to 75 - The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class ? ~ 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Shengjing hospital of China medical university | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shengjing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the change of hemodynamic parameter MAP in mmHg | intraoperative | Yes | |
Primary | the change of hemodynamic parameters HR in beat per minutes | intraoperative | Yes | |
Primary | the change of blood SPO2 in percentage | intraoperative | Yes | |
Primary | the change of blood pH | intraoperative | Yes | |
Primary | the change of blood PCO2 in mmHg | intraoperative | Yes | |
Primary | the change of blood PO2 in mmHg | intraoperative | Yes | |
Secondary | the change of Plasma concentration of TNF-a in pg/mL | intraoperative | Yes | |
Secondary | post-operative pulmonary complications | in the first 5 days after surgery | Yes | |
Secondary | the change of plasma concentration of IL-1ß | intraoperative | Yes |
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