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

Inflammation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193477
• Other study ID #: Gjian
• Status: Completed
• Phase: N/A
• First received: July 6, 2014
• Last updated: March 5, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Systemic Inflammatory Response Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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-a,Interferon-?(IFN-?),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.	30 minutes before general anesthesia induction and 1st and 3rd day after the surgery	No
Secondary	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	No