Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions

Acute Kidney Injury Clinical Trial

— ROBOTNGAL  

Official title:

Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01898897
• Other study ID #: Iuliu Hatieganu University
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2013
• Last updated: July 15, 2013
• Start date: March 2010
• Est. completion date: May 2015

Study information

• Verified date: July 2013
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Orsolya Mihaly, MD, Phd
• Email: kerekesorsolya[@]yahoo.com
• Is FDA regulated: No
• Health authority: Romania: National Agency for Medicines and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.

Description:

The study investigates the effect of combined anesthesia on occurrence of acute kidney injury in robot assisted laparoscopic urogenital surgery.Renal function is assessed according to the new RIFLE and AKIN criteria, and by determining serum and urinary neutrophil gelatinase associated lipocalin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• signed the informed consent without previous renal function alteration respiratory and hemodynamic stability

Exclusion Criteria:

• refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Adverse Anesthesia Outcome
• Adverse Effect of Other General Anesthetics
• Anesthesia; Reaction

Intervention

Procedure:
• epidural catheter insertion
A catheter is placed in the epidural space at thoracic level. Analgesia is realised with local anesthetics (Bupivacaine plain 0.125%), administered from the beginning of surgical intervention and 12 hours postoperative on the postoperative care unit and intensive care unit at a rate of 6-8 ml/hour.
• robot assisted laparoscopic urogenital surgery
The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.

Locations

Country	Name	City	State
Romania	City Clinical Hospital Cluj Urology and ICU Departments	Cluj Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (5)

Curatolo M. Adding regional analgesia to general anaesthesia: increase of risk or improved outcome? Eur J Anaesthesiol. 2010 Jul;27(7):586-91. doi: 10.1097/EJA.0b013e32833963c8. Review. — View Citation

Kurosawa S, Kato M. Anesthetics, immune cells, and immune responses. J Anesth. 2008;22(3):263-77. doi: 10.1007/s00540-008-0626-2. Epub 2008 Aug 7. Review. — View Citation

Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. — View Citation

Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. — View Citation

Wolf AR. Effects of regional analgesia on stress responses to pediatric surgery. Paediatr Anaesth. 2012 Jan;22(1):19-24. doi: 10.1111/j.1460-9592.2011.03714.x. Epub 2011 Oct 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute kidney injury	Acute kidney injury, previously referred as acute renal failure is a serious complication of major surgery. The diagnostic of subclinical alteration of kidney function is possible with the novel biomarkers, such as neutrophil gelatinase associated lipocalin (NGAL). Modified NGAL values can be detected in patients urine and serum at 6 hours from the renal injury.; In our study, we assessed the renal function by determining basal creatinine and follow the creatinine values 4 days postoperative. Acute kidney injury (AKI)is defined as a 0.3 mg/ml rise in serum creatinine from baseline, according to the AKIN criteria.; NGAL is measured (with ELISA technique) at 6 hours and 12 hours from the induction of the anesthesia.; The incidence of AKI will be compared in the different anesthesia techniques for robot assisted urogenital laparoscopic surgery.	4 days	No
Secondary	postoperative outcome	We study the effect of combined anesthesia (general anesthesia with epidural anesthesia and postoperative analgesia for 12 hours)on the postoperative outcome of patients who underwent robot assisted laparoscopic surgery. The endpoints that are discussed are perioperative morbidity, postoperative rehabilitation and the modification of host immune response to surgery.; Postoperative rehabilitation is assessed by quality of recovery score (QoR-40). The modification of immune response is assessed by determining IL6, IL10 and TNFalfa levels.; Post-prostatectomy increase in PSA (prostate specific antigen)indicates biochemic cancer recurrence.	10 days	No