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NCT Number: NCT02193477

Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery

The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer

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Key information

Conditions

Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fourth Military Medical University

Xi’an, Shanxi, 710032, China

About this study

Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.

TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.

Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.

Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>30yrs,<75yrs
  • ASA 1-2
  • Scheduled for radical surgery for gastric cancer under general anesthesia；
  • Informed consented

Exclusion criteria

  • Patients with implanted pacemakers
  • Patients with severe hypertension or cardiac dysfunction；
  • Patients with severe pulmonary disease
  • Patients with hemoglobin<90g/L

Treatment and study plan

TEAS

Device

Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

Sham TEAS

Device

Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

Primary outcomes

  1. Incidence rate of SIRS

    Time frame: 1st day after surgery

    SIRS is defined as 2 or more of the following variables :

    • Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F)
    • Heart rate of more than 90 beats per minute
    • Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg
    • Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms)

    Incidence rate of SIRS is calculated using the following formula:

    (Number of SIRS Cases within the group) / (Number of Cases within the group)

Secondary outcomes

  1. Change of Inflammatory cytokines

    Time frame: 30 minutes before general anesthesia induction and 1st and 3rd day after the surgery

    Venous blood samples were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,TNF-α,Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.

  2. Incidence rate of SIRS

    Time frame: 3rd day after surgery

    SIRS is defined as 2 or more of the following variables :

    Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F) Heart rate of more than 90 beats per minute Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg Abnormal white blood cell count (>12,000/µL or < 4,000/µL or >10% immature granulocyte forms)

    Incidence rate of SIRS is calculated using the following formula:

    (Number of SIRS Cases within the group) / (Number of Cases within the group)

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS)on the Incidence Rate of Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Radical Surgery for Gastric Cancer

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 17, 2014
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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