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

NCT02013596 | Completed DMC

• 1 other identifier: XJH-A-2013-08-2
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Dysfunction Transient; Renal Function Disorder

Keywords

hepatic dysfunction; renal dysfunction; pneumoperitoneum; Transcutaneous electric stimulation

Outcome Measures

Primary Outcomes (1)

• Incidence of renal or hepatic dysfunction

  percentage of patients with renal or hepatic dysfunction

  20min after pneumoperitoneum

Secondary Outcomes (2)

• Change of hepatic function

  20min after pneumoperitoneum

• Change of renal function

  20min after pneumoperitoneum

Study Arms (3)

Control

NO INTERVENTION

Patients were given no TEAS

TEAS Pretreatment

EXPERIMENTAL

Patients were given 30min of TEAS before pneumoperitoneum

Other: TEAS pretreatment

TEAS Treatment

EXPERIMENTAL

Patients were given 30min of TEAS during pneumoperitoneum

Other: TEAS treatment

Interventions

TEAS pretreatment OTHER

Electric stimulation was given through electrode attached to specific acupoints for 30mins before anesthesia induction

TEAS Pretreatment

TEAS treatment OTHER

Transcutaneous Electrical Acupoint Stimulation was given to the patient at the same time of the start of anesthesia induction for 30mins

TEAS Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhihong LU: lead

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (9)

• 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.

  PMID: 23605192 BACKGROUND

• 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.

  PMID: 22609982 BACKGROUND

• 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.

  PMID: 23983283 BACKGROUND

• 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.

  PMID: 21507469 BACKGROUND

• 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.

  PMID: 21490821 BACKGROUND

• 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.

  PMID: 22824851 BACKGROUND

• 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.

  PMID: 22619616 BACKGROUND

• 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.

  PMID: 21987614 BACKGROUND

• 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.

  PMID: 21253398 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Renal Insufficiency; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Peritoneal Diseases

Study Officials

• zhihong Lu, MD

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: December 17, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

CN (1)