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

Primary Purpose

Hepatic Dysfunction Transient, Renal Function Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEAS pretreatment
TEAS treatment
Sponsored by
Zhihong LU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Dysfunction Transient focused on measuring hepatic dysfunction, renal dysfunction, pneumoperitoneum, Transcutaneous electric stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

TEAS Pretreatment

TEAS Treatment

Arm Description

Patients were given no TEAS

Patients were given 30min of TEAS before pneumoperitoneum

Patients were given 30min of TEAS during pneumoperitoneum

Outcomes

Primary Outcome Measures

Incidence of renal or hepatic dysfunction
percentage of patients with renal or hepatic dysfunction

Secondary Outcome Measures

Change of hepatic function
the increase of hepatic ALT and AST after pneumoperitoneum
Change of renal function
Change of BUN and Cr after pneumoperitoneum

Full Information

First Posted
September 16, 2013
Last Updated
January 13, 2016
Sponsor
Zhihong LU
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1. Study Identification

Unique Protocol Identification Number
NCT02013596
Brief Title
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hepatic and Renal Dysfunction After Pneumoperitoneum
Acronym
TRIP
Official Title
Effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Hepatic and Renal Function Impaired by Pneumoperitoneum: a Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhihong LU

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Dysfunction Transient, Renal Function Disorder
Keywords
hepatic dysfunction, renal dysfunction, pneumoperitoneum, Transcutaneous electric stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients were given no TEAS
Arm Title
TEAS Pretreatment
Arm Type
Experimental
Arm Description
Patients were given 30min of TEAS before pneumoperitoneum
Arm Title
TEAS Treatment
Arm Type
Experimental
Arm Description
Patients were given 30min of TEAS during pneumoperitoneum
Intervention Type
Other
Intervention Name(s)
TEAS pretreatment
Intervention Description
Electric stimulation was given through electrode attached to specific acupoints for 30mins before anesthesia induction
Intervention Type
Other
Intervention Name(s)
TEAS treatment
Intervention Description
Transcutaneous Electrical Acupoint Stimulation was given to the patient at the same time of the start of anesthesia induction for 30mins
Primary Outcome Measure Information:
Title
Incidence of renal or hepatic dysfunction
Description
percentage of patients with renal or hepatic dysfunction
Time Frame
20min after pneumoperitoneum
Secondary Outcome Measure Information:
Title
Change of hepatic function
Description
the increase of hepatic ALT and AST after pneumoperitoneum
Time Frame
20min after pneumoperitoneum
Title
Change of renal function
Description
Change of BUN and Cr after pneumoperitoneum
Time Frame
20min after pneumoperitoneum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhihong Lu, MD
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23605192
Citation
Westgarth-Taylor C, de Lijster L, van Bogerijen G, Millar AJ, Karpelowsky J. A prospective assessment of renal oxygenation in children undergoing laparoscopy using near-infrared spectroscopy. Surg Endosc. 2013 Oct;27(10):3696-704. doi: 10.1007/s00464-013-2950-3. Epub 2013 Apr 19.
Results Reference
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PubMed Identifier
22609982
Citation
de Barros RF, Miranda ML, de Mattos AC, Gontijo JA, Silva VR, Iorio B, Bustorff-Silva JM. Kidney safety during surgical pneumoperitoneum: an experimental study in rats. Surg Endosc. 2012 Nov;26(11):3195-200. doi: 10.1007/s00464-012-2322-4. Epub 2012 May 19.
Results Reference
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PubMed Identifier
23983283
Citation
Parikh BK, Shah VR, Modi PR, Butala BP, Parikh GP. Anaesthesia for laparoscopic kidney transplantation: Influence of Trendelenburg position and CO2 pneumoperitoneum on cardiovascular, respiratory and renal function. Indian J Anaesth. 2013 May;57(3):253-8. doi: 10.4103/0019-5049.115607.
Results Reference
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PubMed Identifier
21507469
Citation
Wiesenthal JD, Fazio LM, Perks AE, Blew BD, Mazer D, Hare G, Honey RJ, Pace KT. Effect of pneumoperitoneum on renal tissue oxygenation and blood flow in a rat model. Urology. 2011 Jun;77(6):1508.e9-15. doi: 10.1016/j.urology.2011.02.022. Epub 2011 Apr 19.
Results Reference
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PubMed Identifier
21490821
Citation
Ahn JH, Lim CH, Chung HI, Choi SU, Youn SZ, Lim HJ. Postoperative renal function in patients is unaltered after robotic-assisted radical prostatectomy. Korean J Anesthesiol. 2011 Mar;60(3):192-7. doi: 10.4097/kjae.2011.60.3.192. Epub 2011 Mar 30.
Results Reference
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PubMed Identifier
22824851
Citation
Hoekstra LT, Ruys AT, Milstein DM, van Samkar G, van Berge Henegouwen MI, Heger M, Verheij J, van Gulik TM. Effects of prolonged pneumoperitoneum on hepatic perfusion during laparoscopy. Ann Surg. 2013 Feb;257(2):302-7. doi: 10.1097/SLA.0b013e31825d5b2b.
Results Reference
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PubMed Identifier
22619616
Citation
Eryilmaz HB, Memis D, Sezer A, Inal MT. The effects of different insufflation pressures on liver functions assessed with LiMON on patients undergoing laparoscopic cholecystectomy. ScientificWorldJournal. 2012;2012:172575. doi: 10.1100/2012/172575. Epub 2012 Apr 24.
Results Reference
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PubMed Identifier
21987614
Citation
Li J, Liu YH, Ye ZY, Liu HN, Ou S, Tian FZ. Two clinically relevant pressures of carbon dioxide pneumoperitoneum cause hepatic injury in a rabbit model. World J Gastroenterol. 2011 Aug 21;17(31):3652-8. doi: 10.3748/wjg.v17.i31.3652.
Results Reference
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PubMed Identifier
21253398
Citation
Jeong GA, Cho GS, Shin EJ, Lee MS, Kim HC, Song OP. Liver function alterations after laparoscopy-assisted gastrectomy for gastric cancer and its clinical significance. World J Gastroenterol. 2011 Jan 21;17(3):372-8. doi: 10.3748/wjg.v17.i3.372.
Results Reference
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Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hepatic and Renal Dysfunction After Pneumoperitoneum

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