Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions

NCT01898897 | Unknown DMC

• 1 other identifier: Iuliu Hatieganu University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• postoperative outcome

  10 days

Study Arms (2)

robot general anesthesia

ACTIVE COMPARATOR

General anesthesia for robot assisted laparoscopic urogenital surgery includes premedication with alprazolam (0.5 mg per os), induction with sufentanil, propofol (1-2 mg/kg), neuromuscular blocking agents (rocuronium 0.5 mg/kg) to facilitate tracheal intubation. Anesthesia is maintained with volatile agents (sevoflurane, desflurane) and reinjection of rocuronium and sufentanil as needed. Robotic assisted laparoscopic interventions are realised with Da Vinci surgical robot, known to assure a minimally invasive approach with good results in urologic surgery. The system consists of an ergonomic surgeon console, a patient cart with four interactive robotic arms, a 3D high resolution visualization interface and specific EndoWrist articulated tools.

Procedure: robot assisted laparoscopic urogenital surgery

robot combined anesthesia

EXPERIMENTAL

Combined anesthesia is defined as association of epidural analgesia to general anesthesia. Epidural catheter is inserted at low thoracic level in the operation theatre before the induction of anesthesia. Correct position is verified with 15 mg bupivacaine plain 0.5%. Infusion is started after the incision at a rate of 6-8 ml/ hour.Epidural continuous infusion of local anesthetic is maintained 12 hours postoperative in the postoperative anesthesia care unit.

Procedure: epidural catheter insertion; Procedure: robot assisted laparoscopic urogenital surgery

Interventions

epidural catheter insertion PROCEDURE

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.

Also known as: peridural anesthesia and analgesia

robot combined anesthesia

robot assisted laparoscopic urogenital surgery PROCEDURE

The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.

robot combined anesthesia; robot general anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

City Clinical Hospital Cluj Urology and ICU Departments

Cluj-Napoca, Cluj, 400139, Romania

RECRUITING

Related Publications (5)

• 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.

  PMID: 18685933 BACKGROUND

• 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. doi: 10.1016/S0140-6736(02)08266-1.

  PMID: 11965272 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• 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.

  PMID: 20404731 RESULT

• 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.

  PMID: 21999144 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Anesthesia, Epidural; Analgesia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Daniela Ionescu, MD, Phd

  Iuliu Hatieganu University of Medicine

  STUDY DIRECTOR

Central Study Contacts

Orsolya Mihaly, MD, Phd

CONTACT

kerekesorsolya@yahoo.com

Sorana Bolboaca, MD, Phd

CONTACT

sbolboaca@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 15, 2013
• Study Start: March 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

RO (1)