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Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

Sponsor
Tianjin Nankai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03724656
Collaborator
(none)
600
Enrollment
2
Arms
32.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: acupuncture treatment
  • Device: sham acupuncture treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Biochemical tests [12 months]

    Plasma motilin，gastrin ，Vasoactive intestinal peptide (VIP)，SOD（Superoxide Dismutase） and MDA（Malonaldehyde）

  2. bowel sounds and defecation [an average of 1 year]

    record the recovery time of postoperative bowel sounds and defecation

  3. Postoperative nausea and vomiting [12 months]

    Record the incidence of postoperative nausea and vomiting in patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tianjin Nankai Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jianbo Yu, Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor Affiliation: Tianjin Nankai Hospital, Tianjin Nankai Hospital
ClinicalTrials.gov Identifier:
NCT03724656
Other Study ID Numbers:
  • Gastrointestinal RCT
First Posted:
Oct 30, 2018
Last Update Posted:
Mar 8, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jianbo Yu, Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor Affiliation: Tianjin Nankai Hospital, Tianjin Nankai Hospital
Transcutaneous Acupoint Electrical Stimulation
non-gastrointestinal abdominal surgery
gastrointestinal motility

Study Results

No Results Posted as of Mar 8, 2019