Effects of Acupuncture Stimulation on Systemic Inflammation

Shanghai Jiao Tong University

Status: Unknown

Conditions: Nonsmall Cell Lung Cancer

Treatments: Procedure: Sham stimulation; Procedure: Acupuncture stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02951611

Acu20161023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Sham stimulation

Sham Comparator group

Description:

Put the electrodes on SI3, SJ6, PC6 and LI4 without stimulation.

Treatment:

Procedure: Sham stimulation

Treatment: Acupuncture stimulation

Experimental group

Description:

Stimulate the SI3, SJ6, PC6 and LI4 since 30 minutes before anesthesia induction until the end of operation. Stimulate again at above acupoints at 6 and 24h after operation, for 30 minutes each time. The stimulation frequency is 2/100Hz. The stimulation current is two to three times of the lowest current that the patient can feel.

Treatment:

Procedure: Acupuncture stimulation