Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

March 6, 2019 updated by: Jianbo Yu, Tianjin Nankai Hospital

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

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Nankai Hospital

Investigators

  • Study Chair: Yu Jianbo, Professor, Nankai Hospital of Tianjin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

October 28, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Gastrointestinal RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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