NCT03724656

Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Tianjin Nankai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Dysfunction

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2018-10-30
• Last updated: 2019-03-08