Influence of Anesthesia Technique on Postoperative Evolution After Urogenital Surgical Interventions (ROBOTNGAL)

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Unknown

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01898897

Iuliu Hatieganu University

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

robot general anesthesia

Active Comparator group

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.

Treatment:

Procedure: robot assisted laparoscopic urogenital surgery

robot combined anesthesia

Experimental group

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.

Treatment:

Procedure: epidural catheter insertion

Procedure: robot assisted laparoscopic urogenital surgery