NCT02239159

Brief Summary

The investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. And TEAS may induce the production of endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators believe this intervention will reduce the subsequent incidence, duration and severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after digestive surgery in elderly patients .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
748

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration 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

April 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

April 6, 2014

Last Update Submit

July 6, 2017

Conditions

Postoperative ComplicationsSurgery

Keywords

transcutaneous electric acupoint stimulationelderly patients

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability

    participants will be followed from the end of the surgery to 30 days after surgery

Secondary Outcomes (5)

  • Number of participants died of all causes

    Participants will be followed from the end of the surgery to 30 days after surgery

  • Length of ICU stay

    participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days

  • Number of participants with ICU admission

    participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days

  • Number of participants with Systemic Inflammatory Response Syndrome(SIRS)

    Participants will be followed from the end of the surgery to 30 days after surgery

  • Length of hospital stay

    participants will be followed for the duration of hospital stay after surgery, an expected average of 7days

Study Arms (3)

Control

NO INTERVENTION

Electrodes will be attached, but stimulation will not be given

Non-acupoint TES

SHAM COMPARATOR

TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints

Other: TES(transcutaneous electric stimulation)

Acupoint TES

EXPERIMENTAL

Transcutaneous stimulation will be given through acupoints

Other: TES(transcutaneous electric stimulation)

Interventions

TES(transcutaneous electric stimulation)OTHER

Stimulation will be given through electrodes attached to the skin

Acupoint TESNon-acupoint TES

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Provide written informed consent
  • Age ≥65 years of age
  • Elective digestive surgery under general anesthesia

You may not qualify if:

  • ASA(American Society of Anesthesiologists) status\> Ⅲ
  • Patients undergoing surgery within 12 h of admission to hospital
  • Patients undergoing surgery of the chest
  • Patients suffered from neurologic disorder or impaired mental state
  • Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
  • Patients with experience of transcutaneous electrical stimulation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lize Xiong, PhD

    Air Force Military Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 6, 2014

First Posted

September 12, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

CN(1)