Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions

NCT ID: NCT01898897

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

robot general anesthesia

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.

Group Type ACTIVE_COMPARATOR

robot assisted laparoscopic urogenital surgery

Intervention Type PROCEDURE

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

robot combined anesthesia

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.

Group Type EXPERIMENTAL

epidural catheter insertion

Intervention Type 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.

robot assisted laparoscopic urogenital surgery

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

robot assisted laparoscopic urogenital surgery

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

peridural anesthesia and analgesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mihaly Orsolya

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniela Ionescu, MD, Phd

Role: STUDY_DIRECTOR

Iuliu Hatieganu University of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City Clinical Hospital Cluj Urology and ICU Departments

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Romania

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Orsolya Mihaly, MD, Phd

Role: CONTACT

Sorana Bolboaca, MD, Phd

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Orsolya Mihaly, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18685933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11965272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10740540 (View on PubMed)

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.

Reference Type RESULT
PMID: 20404731 (View on PubMed)

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.

Reference Type RESULT
PMID: 21999144 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Iuliu Hatieganu University

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lidocaine Infusion in Radical Cystectomy
NCT03047057 COMPLETED PHASE2