Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

Study Overview
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Brief Summary
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Research name: Effects of intraoperative stimulation of acupoints on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery. Research center: Multicenter research Research design: A randomized controlled study method would be used in this study, in which the investigators would provide electroacupuncture on the basis of general anesthesia for non-gastrointestinal abdominal surgery. The effects of electroacupuncture on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery will be observed and compared with the control group. Research population: Patients who are greater or equal to 18 years old and less than 64 years old , meanwhile intend to receive selective/limited non-gastrointestinal surgery under general anesthesia. Number of participants: 600 Interventions: The treatment group received electroacupuncture intervention 30 minutes before induction of anesthesia. In the treatment group, bilateral Neiguan point, bilateral Zusanli point and bilateral Hegu point were selected, then electroacupuncture was applied and the needle was retained until the end of operation. The control group was treated with non-acupoint shallow acupuncture method. The needle was inserted 5 cm beside the acupoint and the needling depth was less than 2 mm. At the same time, the manual stimulation was avoided, Deqi was not obtained, electroacupuncture was applied, electric current was regulated, and the needle was retained until the end of the operation.

Detailed Description
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This study is a large sample, randomized, double-blinded, placebo-controlled and long-term follow-up design. In this study, bilateral Neiguan(PC6), bilateral Zusanli(ST36)and bilateral Hegu (LI4)points were selected for perioperative TAES treatment. accompanied with evaluating the postoperative gastrointestinal motility, the incidence of postoperative nausea and vomiting , as well as the effects on postoperative NRS pain and sleep quality scores . To clarify the effect of TAES on the postoperative spontaneous voiding in patients for laparoscopic surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world.

Official Title
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Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery in Patients Undergoing Non-gastrointestinal Abdominal Surgery: A Multicenter Randomized Controlled Trial

Conditions
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Gastrointestinal Dysfunction

Intervention / Treatment
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* Device: acupuncture treatment
* Device: sham acupuncture treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Subjects enrolled in this study must accord with all of the following criteria: Age ≥ 18 years old and <64 years old, gender, ethnicity is not limited; It is intended to selective/limited non-gastrointestinal surgery under general anesthesia; Agree to participate in the study and sign an informed consent form; Exclusion Criteria: Refusing to participate in this study; Patients with cardiac pacemakers and some special groups, such as pregnant women and those who have had many long-term acupuncture treatment experience; Patients with peptic ulcer, perforation or obstruction; Patients with chronic liver and renal dysfunction, and those who use β-blockers or antihypertensive drugs; The attending doctors or researchers believe that there are other unsuitable situations for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture treatment<br>Patients in the TAES treatment group received Transcutaneous Acupoint Electrical Stimulation(TAES) 30 minutes before induction of anesthesia. Bilateral Neiguan（PC6）, bilateral Zusanli（ST36）and bilateral Hegu （LI4）point were selected by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After Deqi, electroacupuncture stimulation apparatus is connected and maintained until the end of operation. | Device: acupuncture treatment<br>* TAES treatment 30 minutes before induction of anesthesia. Bilateral Neiguan（PC6）, bilateral Zusanli（ST36）and bilateral Hegu （LI4）point were selected by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After Deqi, electroacupuncture stimulation apparatus is connected and maintained until the end of operation.<br>|
| Sham Comparator: Sham acupuncture treatment<br>The control group was treated with non-acupoint shallow acupuncture method. The needle was inserted 5 cm beside the acupoint and the needling depth was less than 2 mm. At the same time, the manual stimulation and Deqi was avoided. | Device: sham acupuncture treatment<br>* Participants in the sham acupuncture group received shallow needling (0.30mm×25mm) at bilateral sham points(nonacupoints located 5cm beside acupoints, about 20mm). The control group was treated with non-acupoint shallow acupuncture method and the needling depth was less than 2 mm. At the same time, the manual stimulation and Deqi was avoided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative venting | Record the time from the end of the procedure to the patient's first venting after operation | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical tests | Plasma motilin，gastrin ，Vasoactive intestinal peptide (VIP)，SOD（Superoxide Dismutase） and MDA（Malonaldehyde） | 12 months | 
| bowel sounds and defecation | record the recovery time of postoperative bowel sounds and defecation | an average of 1 year | 
| Postoperative nausea and vomiting | Record the incidence of postoperative nausea and vomiting in patients | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous Acupoint Electrical Stimulation, non-gastrointestinal abdominal surgery, gastrointestinal motility