Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Reperfusion Injury Clinical Trial

Official title:

Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02850471
• Other study ID #: pulmonary protection
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: July 21, 2016
• Last updated: July 29, 2016
• Start date: March 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Reperfusion Injury

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Shengjing hospital of China medical university	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

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