NCT02951611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

October 29, 2016

Last Update Submit

March 16, 2017

Conditions

Nonsmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • serum TNF-α level

    at 25 hour after surgery

  • serum IL-1β level

    at 25 hour after surgery

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Sham stimulation

SHAM COMPARATOR

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

Procedure: Sham stimulation

Treatment: Acupuncture stimulation

EXPERIMENTAL

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

Interventions

Acupuncture stimulationPROCEDURE

Transcutaneous electrical acupoint stimulation on SI3, SJ6, PC6 and LI4

Treatment: Acupuncture stimulation
Sham stimulationPROCEDURE

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

Sham stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jie Tian, PhD,MD

CONTACT

86-21-68383702vaseline2001@hotmail.com

Fan Zhang

CONTACT

86-21-68383702597158323@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 1, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 17, 2017

Record last verified: 2016-10

Locations

CN(1)