Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.
A partial nephrectomy is accompanied by ischemia time, followed by reperfusion. This frequently leads to a kidney injury of the remained tissue and decrease of the renal function after surgery. As it was shown that Xenon has protective properties against ischemia/reperfusion injury, the investigators hypothesize that Xenon application during partial nephrectomy leads to a stronger nephroprotection than an anesthesia with Isoflurane. The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anesthesia for partial nephrectomy and will therefore necessarily be unblinded to the treatment conditions. Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive Xenon for maintenance of balanced anesthesia for partial nephrectomy. Group 2 (Isoflurane) will receive Isoflurane for the same surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia.
Evaluation of the maximum decrease of glomerular filtration rate (GFR) within 7 days after partial nephrectomy surgery. Maximum decrease will be assessed by the difference between the baseline value of GFR and the minimum value of GFR after surgery.
Time frame: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Ischaemia time
Time frame: Intraoperatively
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Duration of xenon/isoflurane exposition before and after the kidney ischemia time.
Time frame: Intraoperatively
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Tumor size and histology, if applicable detection of hypoxia-inducible factor 1α (HIF-1α) in healthy resection border tissue
Time frame: Intraoperatively until discharge from hospital
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Measurement of macrophage migration inhibitory factor (MIF) in serum
Time frame: Intraoperatively and within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Course of GFR determined with the Cystatin C value in serum
Time frame: preaoperativ and Within the first 7 postoperative days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Course of creatinine value in serum
Time frame: preaoperativ and Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Urine output within the first 48houres after surgery
Time frame: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
If applicable determination of kidney injury molecule-1 (KIM-1)or neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: Within the first 7 postoperative days
Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
Determination of acute kidney failure according to the AKIN classification
Time frame: Within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Doses and concentration of study treatments
Time frame: intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
The peri-anaesthetic respiratory profile
Time frame: intraoperative and within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
The peri-anaesthetic haemodynamic profile
Time frame: intraoperative and within the first 7 postoperative days
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
Intra-operative blood loss
Time frame: intraoperative
Safety criteria for using xenon-anaesthesia during partial nephrectomy.
The incidence of adverse event (AE) and serious adverse event (SAE)
Time frame: intraoperative and within the first 7 postoperative days