Back to resultsInfluence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions (ROBOTNGAL)
Primary Purpose
Anesthesia; Reaction, Adverse Effect of Other General Anesthetics, Adverse Anesthesia Outcome
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
epidural catheter insertion
robot assisted laparoscopic urogenital surgery
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia; Reaction
Eligibility Criteria
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
Sites / Locations
- City Clinical Hospital Cluj Urology and ICU DepartmentsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
robot general anesthesia
robot combined anesthesia
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01898897
First Posted
July 1, 2013
Last Updated
July 15, 2013
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT01898897
Brief Title
Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions
Acronym
ROBOTNGAL
Official Title
Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Reaction, Adverse Effect of Other General Anesthetics, Adverse Anesthesia Outcome, Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robot general anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
robot combined anesthesia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
epidural catheter insertion
Other Intervention Name(s)
peridural anesthesia and analgesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
robot assisted laparoscopic urogenital surgery
Intervention Description
The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.
Primary Outcome Measure Information:
Title
acute kidney injury
Description
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
Secondary Outcome Measure Information:
Title
postoperative outcome
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orsolya Mihaly, MD, Phd
Email
kerekesorsolya@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sorana Bolboaca, MD, Phd
Email
sbolboaca@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ionescu, MD, Phd
Organizational Affiliation
Iuliu Hatieganu University of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
City Clinical Hospital Cluj Urology and ICU Departments
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400139
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orsolya Mihaly, MD, PhD
Email
kerekesorsolya@yahoo.com
First Name & Middle Initial & Last Name & Degree
Orsolya Mihaly, MD, Phd
12. IPD Sharing Statement
Citations:
PubMed Identifier
18685933
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.
Results Reference
background
PubMed Identifier
11965272
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. doi: 10.1016/S0140-6736(02)08266-1.
Results Reference
background
PubMed Identifier
10740540
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. doi: 10.1093/oxfordjournals.bja.a013366.
Results Reference
background
PubMed Identifier
20404731
Citation
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.
Results Reference
result
PubMed Identifier
21999144
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.
Results Reference
result
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Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions
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