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

Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial

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 .

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Surgery
• Intervention / Treatment: Other: TES(transcutaneous electric stimulation)

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.

• Study Type: Interventional
• Enrollment (Actual): 748
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital,Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Electrodes will be attached, but stimulation will not be given
Sham Comparator: Non-acupoint TES; TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints	Other: TES(transcutaneous electric stimulation); Stimulation will be given through electrodes attached to the skin
Experimental: Acupoint TES; Transcutaneous stimulation will be given through acupoints	Other: TES(transcutaneous electric stimulation); Stimulation will be given through electrodes attached to the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Study Chair: Lize Xiong, PhD, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 6, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: elderly patients; transcutaneous electric acupoint stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: XJH-A-2014-02-21-1