Clinical trial NCT02951611: Effects of Acupuncture Stimulation on Systemic Inflammation
Official title: Effects of Acupuncture Stimulation on Systemic Inflammation in Patients Undergoing Video-assisted Thoracoscopic Lobectomy Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonsmall Cell Lung Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum TNF-α level
timeFrame: at 25 hour after surgery
measure: serum IL-1β level
timeFrame: at 25 hour after surgery
Secondary outcomes:
measure: serum TNF-α level
timeFrame: at 1 hour after surgery
measure: serum IL-1β level
timeFrame: at 1 hour after surgery
measure: serum CXCL8 level
timeFrame: at 1 hour after surgery
measure: serum CXCL8 level
timeFrame: at 25 hour after surgery
measure: serum Th1/Th2 ratio
timeFrame: at 1 hour after surgery
measure: serum Th1/Th2 ratio
timeFrame: at 25 hour after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
References: