Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

Not Applicable

• Conditions: Gastrointestinal Dysfunction
• Interventions: Device: acupuncture treatment; Device: sham acupuncture treatment

• Registration Number: NCT03724656
• Lead Sponsor: Tianjin Nankai Hospital

Brief Summary

1. Research name: Effects of intraoperative stimulation of acupoints on postoperative gastrointestinal motility recovery in patients undergoing non-gastrointestinal abdominal surgery.

2. Research center: Multicenter research

3. 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.

4. 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.

5. Number of participants: 600

6. 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

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.

Study Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Status Verified: 2019-03
• Study Start: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Inclusion Criteria

Subjects enrolled in this study must accord with all of the following criteria:

1. Age ≥ 18 years old and <64 years old, gender, ethnicity is not limited;
2. It is intended to selective/limited non-gastrointestinal surgery under general anesthesia;
3. Agree to participate in the study and sign an informed consent form;

Exclusion Criteria

1. Refusing to participate in this study;
2. Patients with cardiac pacemakers and some special groups, such as pregnant women and those who have had many long-term acupuncture treatment experience;
3. Patients with peptic ulcer, perforation or obstruction;
4. Patients with chronic liver and renal dysfunction, and those who use β-blockers or antihypertensive drugs;
5. The attending doctors or researchers believe that there are other unsuitable situations for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture treatment	acupuncture treatment	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.
Sham acupuncture treatment	sham acupuncture treatment	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.

Primary Outcome Measures

Name	Time	Method
postoperative venting	an average of 1 year	Record the time from the end of the procedure to the patient's first venting after operation

Secondary Outcome Measures

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