Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

Gastrointestinal Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03724656
• Other study ID #: Gastrointestinal RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: November 2021

Study information

• Verified date: March 2019
• Source: Tianjin Nankai Hospital
• Contact: Zhang Yuan, PhD
• Phone: 13642066361
• Email: 13642066361[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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 ß-blockers or antihypertensive drugs;

5. The attending doctors or researchers believe that there are other unsuitable situations for the study.

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction

Intervention

Device:
• acupuncture treatment
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.
• sham acupuncture treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

References & Publications (3)

Güngördük K, Özdemir IA, Güngördük Ö, Gülseren V, Gokçü M, Sanci M. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial. Am J Obstet Gynecol. 2017 Feb;216(2):145.e1-145.e7. doi: 10.1016/j.ajog.2016.10.019. Epub 2016 Oct 22. — View Citation

Lee CH, Kim DK, Yook TH, Sasaki M, Kitamura N. Effectiveness of electroacupuncture at Zusanli (ST36) on the immunohistochemical density of enteroendocrine cells related to gastrointestinal function. J Acupunct Meridian Stud. 2012 Apr;5(2):63-71. doi: 10.1016/j.jams.2012.01.002. Epub 2012 Feb 4. — View Citation

Wang CP, Kao CH, Chen WK, Lo WY, Hsieh CL. A single-blinded, randomized pilot study evaluating effects of electroacupuncture in diabetic patients with symptoms suggestive of gastroparesis. J Altern Complement Med. 2008 Sep;14(7):833-9. doi: 10.1089/acm.2008.0107. — View Citation

Outcome

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