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

Not Applicable

Completed

• Conditions: Inflammation; Systemic Inflammatory Response Syndrome
• Interventions: Device: TEAS; Device: Sham TEAS

• Registration Number: NCT02193477
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-06
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEAS Treatment	TEAS	Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.
Sham TEAS	Sham TEAS	Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.

Primary Outcome Measures

Name	Time	Method
Incidence rate of SIRS	1st day after surgery	SIRS is defined as 2 or more of the following variables : 1. Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F); 2. Heart rate of more than 90 beats per minute; 3. Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg; 4. 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 Outcome Measures

Name	Time	Method
Change of Inflammatory cytokines	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.
Incidence rate of SIRS	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)

Trial Locations

Locations (1)

Fourth Military Medical University; 🇨🇳 Xi'an, Shanxi, China