NCT02193477

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

July 6, 2014

Last Update Submit

March 5, 2015

Conditions

Systemic Inflammatory Response SyndromeInflammation

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of SIRS

    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)

    1st day after surgery

Secondary Outcomes (2)

  • Change of Inflammatory cytokines

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

  • Incidence rate of SIRS

    3rd day after surgery

Study Arms (3)

Control

NO INTERVENTION

Patients were given no TEAS.

TEAS Treatment

EXPERIMENTAL

Patients were given 30min of TEAS before general anesthesia induction, 1th day and 2nd day after surgery.

Device: TEAS

Sham TEAS

SHAM COMPARATOR

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

Device: Sham TEAS

Interventions

TEASDEVICE

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

TEAS Treatment
Sham TEASDEVICE

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

Sham TEAS

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Qiang Wang, MD

    Air Force Military Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor,PhD advisor

Study Record Dates

First Submitted

July 6, 2014

First Posted

July 17, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

CN(1)