Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hepatic and Renal Dysfunction After Pneumoperitoneum (TRIP)

January 13, 2016 updated by: Zhihong LU

Effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Hepatic and Renal Function Impaired by Pneumoperitoneum: a Prospective, Randomized Controlled Trial

The purpose of this study is to compare the effect of TEAS pretreatment and treatment on hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing laparoscopic surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were randomly assigned to three groups, control group and two intervention groups, receiving TEAS before and after general anesthesia induction respectively. TEAS was given through electrodes attached to acupoints. The time for TEAS was 30min. Venous blood samples were collected before and 20min after pneumoperitoneum. Hepatic and renal function index including AST, ALT, ALP, BUN, Cr were measured.

Study Type

Interventional

Enrollment (Actual)

168

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age>18yrs,<60yrs；
  • ASA 1-2；
  • Scheduled for laparoscopic surgery under general anesthesia；
  • Informed consented

Exclusion Criteria:

  • Patients with hepatic or renal dysfunction；
  • Patients with severe hypertension or cardiac dysfunction；
  • Patients with severe pulmonary disease；
  • Patients with hemoglobin<100g/L

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients were given no TEAS
Experimental: TEAS Pretreatment
Patients were given 30min of TEAS before pneumoperitoneum
Other: TEAS pretreatment
Electric stimulation was given through electrode attached to specific acupoints for 30mins before anesthesia induction
Experimental: TEAS Treatment
Patients were given 30min of TEAS during pneumoperitoneum
Other: TEAS treatment
Transcutaneous Electrical Acupoint Stimulation was given to the patient at the same time of the start of anesthesia induction for 30mins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of renal or hepatic dysfunction
Time Frame: 20min after pneumoperitoneum
percentage of patients with renal or hepatic dysfunction
20min after pneumoperitoneum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of hepatic function
Time Frame: 20min after pneumoperitoneum
the increase of hepatic ALT and AST after pneumoperitoneum
20min after pneumoperitoneum
Change of renal function
Time Frame: 20min after pneumoperitoneum
Change of BUN and Cr after pneumoperitoneum
20min after pneumoperitoneum

Collaborators and Investigators

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

Sponsor

Zhihong LU

Investigators

  • Principal Investigator: zhihong Lu, MD, Air Force Military Medical University, China

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

December 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-2013-08-2

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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