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

Surgery Clinical Trial

— AID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239159
• Other study ID #: XJH-A-2014-02-21-1
• Status: Completed
• Phase: N/A
• First received: April 6, 2014
• Last updated: July 6, 2017
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: July 2017
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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> ?

• 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

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery

Intervention

Other:
• TES(transcutaneous electric stimulation)
Stimulation will be given through electrodes attached to the skin

Locations

Country	Name	City	State
China	Xijing Hospital,Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants died of all causes		Participants will be followed from the end of the surgery to 30 days after surgery
Secondary	Length of ICU stay		participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Secondary	Number of participants with ICU admission		participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Secondary	Number of participants with Systemic Inflammatory Response Syndrome(SIRS)		Participants will be followed from the end of the surgery to 30 days after surgery
Secondary	Length of hospital stay		participants will be followed for the duration of hospital stay after surgery, an expected average of 7days