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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02239159
Acronym
AID
Enrollment
748
Registered
2014-09-12
Start date
2014-04-30
Completion date
2016-10-31
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Surgery

Keywords

transcutaneous electric acupoint stimulation, elderly patients

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.

Interventions

OTHERTES(transcutaneous electric stimulation)

Stimulation will be given through electrodes attached to the skin

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerabilityparticipants will be followed from the end of the surgery to 30 days after surgery

Secondary

MeasureTime frame
Number of participants died of all causesParticipants will be followed from the end of the surgery to 30 days after surgery
Length of ICU stayparticipants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Number of participants with ICU admissionparticipants 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 stayparticipants will be followed for the duration of hospital stay after surgery, an expected average of 7days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026