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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

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.

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Control
    • Patients were given no TEAS
  • Experimental: TEAS Pretreatment
    • Patients were given 30min of TEAS before pneumoperitoneum
  • Experimental: TEAS Treatment
    • Patients were given 30min of TEAS during pneumoperitoneum

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhihong LU
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Zhihong LU, Dr. – Air Force Military Medical University, China
  • Overall Official(s)
    • zhihong Lu, MD, Principal Investigator, Air Force Military Medical University, China

References

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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.

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.

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.

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.

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.

Eryılmaz HB, Memiş 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.

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.

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.

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