An interventional study of Acupuncture stimulation and Sham stimulation in Nonsmall Cell Lung Cancer, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-17.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
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Exclusion Criteria:
Put the electrodes on SI3, SJ6, PC6 and LI4 without stimulation.
Procedure: Sham stimulation
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.
Procedure: Acupuncture stimulation
Transcutaneous electrical acupoint stimulation on SI3, SJ6, PC6 and LI4
Put electrodes on SI3, SJ6, PC6 and LI4 without stimulation
serum TNF-α level
Time frame: at 25 hour after surgery
serum IL-1β level
Time frame: at 25 hour after surgery
serum TNF-α level
Time frame: at 1 hour after surgery
serum IL-1β level
Time frame: at 1 hour after surgery
serum CXCL8 level
Time frame: at 1 hour after surgery
serum CXCL8 level
Time frame: at 25 hour after surgery
serum Th1/Th2 ratio
Time frame: at 1 hour after surgery
serum Th1/Th2 ratio
Time frame: at 25 hour after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
RenJi Hospital