Renal Function After Partial Nephrectomy
Conditions
Keywords
Xenon, Isoflurane, Anesthetics, Inhalation, Nephroprotection, Partial nephrectomy, Xenon versus Isoflurane anesthesia
Brief summary
Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.
Detailed description
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.
Interventions
DRUGXenon
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
DRUGIsoflurane
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Sponsors
German Research Foundation
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients willing and able to complete the requirements of this study * Patients with renal carcinoma restricted to one kidney * Patients undergoing partial nephrectomy * Men and women \>= 18 yrs * Informed consent
Exclusion criteria
* Chronic renal failure with a GFR \< 60ml/min/1,73m2 body surface area * American Society of Anesthesiologists (ASA)\>III * Hypersensitivity to the study anaesthetics * Chronic obstructive pulmonary disease (COPD) GOLD IV * Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support * Severe cardial dysfunction New York Heart Association (NYHA) \>III * Disabling neuropsychiatric disorders * Increased intracranial pressure * pregnant or breastfeeding women * Women of childbearing potential * Presumed uncooperativeness or legal incapacity * Lack of informed consent * Participation in a concomitant trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia. | Within the first 7 postoperative days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. | Intraoperatively | Ischaemia time |
| Safety criteria for using xenon-anaesthesia during partial nephrectomy. | intraoperative | Doses and concentration of study treatments |
Countries
Germany
Outcome results
None listed