Nonsmall Cell Lung Cancer
Conditions
Brief summary
60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group and 2. treatment group. Patients in treatment group will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at 6h and 24h after surgery. Patients in the control group received only TIVA general anesthesia and sham electrical stimulation. Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively. Serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured and compared between the two groups.
Detailed description
60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group, who will receive total intravenous anesthesia(TIVA) and sham stimulation; and 2. treatment group, who will receive (TIVA) and transcutaneous electrical acupoint stimulation(TEAS). Since 30 min before induction of anesthesia, patients in treatment group will be stimulated at the 4 acupoints , Houxi、Zhigou、Neiguan and Hegu on both sides by Han's Acupoint Nerve Stimulator(HANS) until the end of the operation. At 6h and 24h after surgery, patients in treatment group will receive TEAS again, for 30 min each time.The frequency was 2/100Hz,the stimulate intensity was the maximum current that could be tolerated when the patients were awake.The control group received only TIVA general anesthesia and sham electrical stimulation.Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively and serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured. The primary outcome measures are serum TNF-alpha and IL-1 beta levels at 25h after surgery. The secondary outcome measures include serum levels of TNF-alpha, IL-1 beta, CXCL8, Th1/Th2 ratio (by calculating IFN gamma/IL-4) at 1h post surgery and serum levels of CXCL8, Th1/Th2 ratio at 25h post surgery.
Interventions
PROCEDUREAcupuncture stimulation
Transcutaneous electrical acupoint stimulation on SI3, SJ6, PC6 and LI4
PROCEDURESham stimulation
Put electrodes on SI3, SJ6, PC6 and LI4 without stimulation
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed Non-Small Cell Lung Carcinoma (NSCLC) and will have elective video-assisted thoracoscopic lobectomy surgery * ASA grade 1-2 * BMI between 18 to 31 kg/m2
Exclusion criteria
* with a history of thoracic surgery * Unwilling to receive transcutaneous electrical acupoint stimulation * BMI ≥ 32 kg/m2 * Infection or scars at the acupoints * periphery nerve injury at the upper or lower limbs * Severe liver, renal, brain or lung disease * Drug abuse * Patients who cannot coordinate with investigators, such as dysphasia，severe infectious disease and disturbance of consciousness * Patients participating other trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum TNF-α level | at 25 hour after surgery |
| serum IL-1β level | at 25 hour after surgery |
Secondary
| Measure | Time frame |
|---|---|
| serum TNF-α level | at 1 hour after surgery |
| serum IL-1β level | at 1 hour after surgery |
| serum CXCL8 level | at 1 hour after surgery |
| serum Th1/Th2 ratio | at 1 hour after surgery |
Countries
China
Contacts
Primary ContactJie Tian, PhD,MD
Backup ContactFan Zhang
Outcome results
None listed