Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting

May 25, 2022 updated by: Zhihong LU

Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery

Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

158

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.

Study Contact

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥18 years
  • scheduled for elective liver surgery under general anesthesia

Exclusion Criteria:

  • body mass index less than 18 kg/m2 or higher than 30 kg/m2
  • American Society of Anesthesiologists status higher than Ⅲ
  • patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
  • suspected or existed abuse of drug or alcohol
  • pregnant or breeding women
  • history of neurological or psychiatric disease

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: transcutaneous electrical acupoint stimulation
Device: transcutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Other Names:
  • TEAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of nausea and vomiting by 24 hours after surgery
Time Frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
from end of surgery to 24 hours after surgery, in a total of 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of nausea and vomiting by 48 hours after surgery
Time Frame: from end of surgery to 48 hours after surgery, in a total of 48 hours
from end of surgery to 48 hours after surgery, in a total of 48 hours
incidence of nausea and vomiting in PACU (post-anesthesia care unit)
Time Frame: from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes
from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes
score of nausea and vomiting by 24 hours after surgery
Time Frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
from end of surgery to 24 hours after surgery, in a total of 24 hours
score of nausea and vomiting by 48 hours after surgery
Time Frame: from end of surgery to 48 hours after surgery, in a total of 48 hours
from end of surgery to 48 hours after surgery, in a total of 48 hours
score of nausea and vomiting in PACU(post-anesthesia care unit)
Time Frame: from end of surgery to discharge from PACU, in an average of 30 minutes
from end of surgery to discharge from PACU, in an average of 30 minutes
Quality of recovery score at 24 hours after surgery
Time Frame: from end of surgery to 24 hours after surgery, in a total of 24 hours
from end of surgery to 24 hours after surgery, in a total of 24 hours
Quality of recovery score at 48 hours after surgery
Time Frame: from end of surgery to 48 hours after surgery, in a total of 48 hours
from end of surgery to 48 hours after surgery, in a total of 48 hours
postoperative in-hospital stay
Time Frame: from end of surgery to discharge from hospital, in an average of 7 days
from end of surgery to discharge from hospital, in an average of 7 days
death by 6 months after surgery
Time Frame: from end of surgery to 6 months after surgery, in a total of 6 months
from end of surgery to 6 months after surgery, in a total of 6 months

Collaborators and Investigators

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

Sponsor

Zhihong LU

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)

May 30, 2022

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-20220410

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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