Anesthesia; ReactionROBOTNGALNCT01898897
Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions
A study testing epidural catheter insertion and robot assisted laparoscopic urogenital surgery in people with Anesthesia; Reaction and Adverse Effect of Other General Anesthetics, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia; Reaction, Adverse Effect of Other General Anesthetics, Adverse Anesthesia Outcome
- What is being tested?
- epidural catheter insertion and robot assisted laparoscopic urogenital surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2010to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed the informed consent without previous renal function alteration respiratory and hemodynamic stability
Who cannot join
- refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases
Trial locations and contacts
1 site in 1 country.
Orsolya Mihaly, MD, Phd contact
Sorana Bolboaca, MD, Phd contact
Romania1 site, 1 recruiting
- Recruiting
City Clinical Hospital Cluj Urology and ICU Departments
Cluj-Napoca, Cluj, 400139
Orsolya Mihaly, MD, PhD, kerekesorsolya@yahoo.com
Orsolya Mihaly, MD, Phd
About this study
Official title: Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury
The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.
Read the 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.
- Conditions
- Anesthesia; Reaction, Adverse Effect of Other General Anesthetics, Adverse Anesthesia Outcome, Acute Kidney Injury
- Being tested
- epidural catheter insertion, robot assisted laparoscopic urogenital surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheter insertionProcedure or surgery
Also called peridural anesthesia and analgesia
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 surgeryProcedure or surgery
The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: epidural catheter insertion; Procedure: robot assisted laparoscopic urogenital surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Secondary outcomes (1)
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMar 2010
- Primary completionJan 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihaly Orsolya, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Daniela Ionescu, MD, Phd, Study director, Iuliu Hatieganu University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898897
- Sponsor's protocol ID
- Iuliu Hatieganu University
- Acronym
- ROBOTNGAL
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18685933Rigg 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.
PubMed 11965272Myles 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.
PubMed 10740540Curatolo 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.
PubMed 20404731Wolf 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.
PubMed 21999144
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT01898897
- Acronym / sponsor ID
- ROBOTNGAL / Iuliu Hatieganu University
- Conditions
- Anesthesia; Reaction, Adverse Effect of Other General Anesthetics, Adverse Anesthesia Outcome, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot general anesthesia | Active comparator | Procedure: robot assisted laparoscopic urogenital surgeryGeneral 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. |
| robot combined anesthesia | Experimental | Procedure: epidural catheter insertion, Procedure: robot assisted laparoscopic urogenital surgeryCombined 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed the informed consent without previous renal function alteration respiratory and hemodynamic stability
Key exclusion criteria (1 listed)
- refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural catheter insertionAlso: peridural anesthesia and analgesiaA 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. | Procedure or surgery | robot combined anesthesia |
| robot assisted laparoscopic urogenital surgeryThe urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies. | Procedure or surgery | robot combined anesthesia, robot general anesthesia |
Primary outcome
acute kidney injury
Time frame: 4 days
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.
1 secondary outcome
postoperative outcome
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Background: PubMed 18685933Kurosawa 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.
- Background: PubMed 11965272Rigg 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.
- Background: PubMed 10740540Myles 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 publication: PubMed 20404731Curatolo 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 publication: PubMed 21999144Wolf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orsolya Mihaly, MD, Phd contact
Sorana Bolboaca, MD, Phd contact
Daniela Ionescu, MD, Phd study director
Iuliu Hatieganu University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter insertion and robot assisted laparoscopic urogenital surgery in people with Anesthesia; Reaction and Adverse Effect of Other General Anesthetics, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orsolya Mihaly, MD, Phd (kerekesorsolya@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01898897, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.