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

NCT ID: NCT02239159

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-10-31

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.

Conditions

Postoperative Complications; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

Electrodes will be attached, but stimulation will not be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Non-acupoint TES

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

Group Type: SHAM_COMPARATOR

TES(transcutaneous electric stimulation)

Intervention Type: OTHER

Stimulation will be given through electrodes attached to the skin

Acupoint TES

Transcutaneous stimulation will be given through acupoints

Group Type: EXPERIMENTAL

TES(transcutaneous electric stimulation)

Intervention Type: OTHER

Stimulation will be given through electrodes attached to the skin

Interventions

TES(transcutaneous electric stimulation)

Stimulation will be given through electrodes attached to the skin

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Zhihong LU

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lize Xiong, PhD

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

XJH-A-2014-02-21-1

Identifier Type: -

Identifier Source: org_study_id