Clincosm LogoSign in Get a demo

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

Sponsor
Zhihong LU (Other)
Overall Status
Completed
CT.gov ID
NCT02013596
Collaborator
(none)
168
Enrollment
1
Location
3
Arms
24
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: TEAS pretreatment
  • Other: TEAS treatment
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Hepatic and Renal Function Impaired by Pneumoperitoneum: a Prospective, Randomized Controlled Trial
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of renal or hepatic dysfunction [20min after pneumoperitoneum]

    percentage of patients with renal or hepatic dysfunction

Secondary Outcome Measures

  1. Change of hepatic function [20min after pneumoperitoneum]

    the increase of hepatic ALT and AST after pneumoperitoneum

  2. Change of renal function [20min after pneumoperitoneum]

    Change of BUN and Cr after pneumoperitoneum

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Zhihong LU

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhihong LU, Dr., Air Force Military Medical University, China
ClinicalTrials.gov Identifier:
NCT02013596
Other Study ID Numbers:
  • XJH-A-2013-08-2
First Posted:
Dec 17, 2013
Last Update Posted:
Jan 14, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Zhihong LU, Dr., Air Force Military Medical University, China
hepatic dysfunction
renal dysfunction
pneumoperitoneum
Transcutaneous electric stimulation
Additional relevant MeSH terms:
Pneumoperitoneum

Study Results

No Results Posted as of Jan 14, 2016