Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery
Primary Purpose
Systemic Inflammatory Response Syndrome, Inflammation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEAS
Sham TEAS
Sponsored by
About this trial
This is an interventional prevention trial for Systemic Inflammatory Response Syndrome
Eligibility Criteria
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
Sites / Locations
- Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Sham Comparator
Arm Label
Control
TEAS Treatment
Sham TEAS
Arm Description
Patients were given no TEAS.
Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.
Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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)
Full Information
NCT ID
NCT02193477
First Posted
July 6, 2014
Last Updated
March 5, 2015
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02193477
Brief Title
Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients were given no TEAS.
Arm Title
TEAS Treatment
Arm Type
Experimental
Arm Description
Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.
Arm Title
Sham TEAS
Arm Type
Sham Comparator
Arm Description
Patients were given 30min of sham TEAS before general anesthesia induction,1th day and 2nd day after surgery.
Intervention Type
Device
Intervention Name(s)
TEAS
Intervention Description
Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
Intervention Type
Device
Intervention Name(s)
Sham TEAS
Intervention Description
Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
Primary Outcome Measure Information:
Title
Incidence rate of SIRS
Description
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)
Time Frame
1st day after surgery
Secondary Outcome Measure Information:
Title
Change of Inflammatory cytokines
Description
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.
Time Frame
30 minutes before general anesthesia induction and 1st and 3rd day after the surgery
Title
Incidence rate of SIRS
Description
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)
Time Frame
3rd day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, MD
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery
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