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Effects of Intraoperative Stimulation of Acupoints on Postoperative Gastrointestinal Motility Recovery

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ClinicalTrials.gov Identifier: NCT03724656
Recruitment Status : Not yet recruiting
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jianbo Yu, 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Dysfunction Device: acupuncture treatment Device: sham acupuncture treatment Not Applicable

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  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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.




Primary Outcome Measures :
  1. 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, and record the recovery time of postoperative bowel sounds and defecation.


Secondary Outcome Measures :
  1. Biochemical tests [ Time Frame: 12 months ]
    Plasma motilin and gastrin, adrenaline, norepinephrine concentration, and adrenocorticotropic hormone (ACTH/μg·L -1) , blood glucose(GLU/mmol·L -1), cortisol(ug/dl), beta-endorphin(pg/ml), superoxidase dismutase (SOD/U·mg-1) and Malondialdehyde(MDA/nmol·L -1) levels were measured.

  2. NRS pain scores [ Time Frame: 12 months ]
    Numerical rating scale(NRS) method is used to evaluate the pain scores of patients (0 points to complete Painless, 10 points to the maximum pain that can be tolerated) The NRS method was used to evaluate the pain scores of patients at resting state and activity (cough) 6-8 hours after operation.

  3. Length of stay in hospital after surgery [ Time Frame: an average of 1 year ]
    The hospitalization time from the patient's surgery to the time of discharge (excluding re-hospitalization)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724656


Contacts
Contact: Zhang Yuan, PhD 13642066361 13642066361@126.com
Contact: Yu Jianbo, Professor (022)27435008 yujianbo11@126.com

Sponsors and Collaborators
Tianjin Nankai Hospital
Investigators
Study Chair: Yu Jianbo, Professor Nankai Hospital of Tianjin

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     History of Changes
Other Study ID Numbers: Gastrointestinal RCT
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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, Tianjin Nankai Hospital:
Transcutaneous Acupoint Electrical Stimulation
non-gastrointestinal abdominal surgery
gastrointestinal motility