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

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

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

Study Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response Syndrome; Inflammation
• Intervention / Treatment: Device: TEAS; Device: Sham TEAS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients were given no TEAS.
Experimental: TEAS Treatment; Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.	Device: TEAS; Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
Sham Comparator: Sham TEAS; Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.	Device: Sham TEAS; Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of SIRS	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)	1st day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Inflammatory cytokines	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.	30 minutes before general anesthesia induction and 1st and 3rd day after the surgery
Incidence rate of SIRS	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)	3rd day after surgery

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Study Chair: Qiang Wang, MD, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 6, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Shock; Syndrome; Inflammation; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: Gjian