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Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients (AID)

Primary Purpose

Postoperative Complications, Surgery

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TES(transcutaneous electric stimulation)
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring transcutaneous electric acupoint stimulation, elderly patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Xijing Hospital,Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Sham Comparator

Experimental

Arm Label

Control

Non-acupoint TES

Acupoint TES

Arm Description

Electrodes will be attached, but stimulation will not be given

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

Transcutaneous stimulation will be given through acupoints

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants died of all causes
Length of ICU stay
Number of participants with ICU admission
Number of participants with Systemic Inflammatory Response Syndrome(SIRS)
Length of hospital stay

Full Information

First Posted
April 6, 2014
Last Updated
July 6, 2017
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02239159
Brief Title
Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients
Acronym
AID
Official Title
Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (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
Yes

5. Study Description

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 .
Detailed Description
Patients older than 65 years old are at higher risk of postoperative morbidity and mortality. With the increasing number of old patients scheduled for digestive surgery, exploring methods to decrease postoperative morbidity is very important. Noninvasive methods may be easier to clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to decrease need for general anesthetics during anesthesia, and to alleviate systemic inflammatory response. Considering the morbidity and mortality after surgery is closely related to use of anesthetics and inflammatory response,TEAS may be a good selection for improving postoperative outcomes.Among the postoperative complications, pulmonary complication and systemic inflammatory response syndrome is with higher incidence, so we will focus on these two complications in our study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Surgery
Keywords
transcutaneous electric acupoint stimulation, elderly patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Electrodes will be attached, but stimulation will not be given
Arm Title
Non-acupoint TES
Arm Type
Sham Comparator
Arm Description
TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints
Arm Title
Acupoint TES
Arm Type
Experimental
Arm Description
Transcutaneous stimulation will be given through acupoints
Intervention Type
Other
Intervention Name(s)
TES(transcutaneous electric stimulation)
Intervention Description
Stimulation will be given through electrodes attached to the skin
Primary Outcome Measure Information:
Title
Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability
Time Frame
participants will be followed from the end of the surgery to 30 days after surgery
Secondary Outcome Measure Information:
Title
Number of participants died of all causes
Time Frame
Participants will be followed from the end of the surgery to 30 days after surgery
Title
Length of ICU stay
Time Frame
participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Title
Number of participants with ICU admission
Time Frame
participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Title
Number of participants with Systemic Inflammatory Response Syndrome(SIRS)
Time Frame
Participants will be followed from the end of the surgery to 30 days after surgery
Title
Length of hospital stay
Time Frame
participants will be followed for the duration of hospital stay after surgery, an expected average of 7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide written informed consent Age ≥65 years of age Elective digestive surgery under general anesthesia Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lize Xiong, PhD
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital,Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients

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