Effects of Acupuncture Stimulation on Systemic Inflammation

Effects of Acupuncture Stimulation on Systemic Inflammation in Patients Undergoing Video-assisted Thoracoscopic Lobectomy Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Nonsmall Cell Lung Cancer
• Intervention / Treatment: Procedure: Sham stimulation; Procedure: Acupuncture stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University
      • Contact: Jie Tian, PhD,MD; Phone Number: 0086-21-68383702; Email: vaseline2001@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham stimulation; Put the electrodes on SI3, SJ6, PC6 and LI4 without stimulation.	Procedure: Sham stimulation; Put electrodes on SI3, SJ6, PC6 and LI4 without stimulation
Experimental: Treatment: Acupuncture 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum TNF-α level	at 25 hour after surgery
serum IL-1β level	at 25 hour after surgery

Secondary Outcome Measures

Outcome 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 CXCL8 level	at 25 hour after surgery
serum Th1/Th2 ratio	at 1 hour after surgery
serum Th1/Th2 ratio	at 25 hour after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 29, 2016
• First Submitted That Met QC Criteria: October 29, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Inflammation
• Other Study ID Numbers: Acu20161023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED