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Completed

NCT Number: NCT02239159

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

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 .

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TES(transcutaneous electric stimulation)

Other

Stimulation will be given through electrodes attached to the skin

Primary outcomes

  1. 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 outcomes

  1. Number of participants died of all causes

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

  2. Length of ICU stay

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

  3. 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

  4. 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

  5. Length of hospital stay

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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: AID

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2014
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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