An interventional study of epidural catheter insertion and robot assisted laparoscopic urogenital surgery in Anesthesia; Reaction, Adverse Effect of Other General Anesthetics and Adverse Anesthesia Outcome, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Status unknown at 1 site in Romania. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-07-16.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Not applicable, Interventional, and Prevention
The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.
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.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 55 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.
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.
Time frame: 4 days
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.
Time frame: 10 days
The record gives a start of Mar 2010, a primary completion of Jan 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Iuliu Hatieganu University of Medicine and Pharmacy