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

Renal Function Disorder Clinical Trial

— TRIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013596
• Other study ID #: XJH-A-2013-08-2
• Status: Completed
• Phase: N/A
• First received: September 16, 2013
• Last updated: January 13, 2016
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Dysfunction Transient
• Liver Diseases
• Pneumoperitoneum
• Renal Function Disorder
• Renal Insufficiency

Intervention

Other:
• TEAS pretreatment
Electric stimulation was given through electrode attached to specific acupoints for 30mins before anesthesia induction
• TEAS treatment
Transcutaneous Electrical Acupoint Stimulation was given to the patient at the same time of the start of anesthesia induction for 30mins

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of renal or hepatic dysfunction	percentage of patients with renal or hepatic dysfunction	20min after pneumoperitoneum	No
Secondary	Change of hepatic function	the increase of hepatic ALT and AST after pneumoperitoneum	20min after pneumoperitoneum	No
Secondary	Change of renal function	Change of BUN and Cr after pneumoperitoneum	20min after pneumoperitoneum	No