Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
NCT Number: NCT01839084
Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Aachen, North Rhine-Westphalia, 52074, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
Other names: Lenoxe
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Other names: Forene
Time frame: 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.
Time frame: Intraoperatively
Ischaemia time
Time frame: Intraoperatively
Duration of xenon/isoflurane exposition before and after the kidney ischemia time.
Time frame: Intraoperatively until discharge from hospital
Tumor size and histology, if applicable detection of hypoxia-inducible factor 1α (HIF-1α) in healthy resection border tissue
Time frame: Intraoperatively and within the first 7 postoperative days
Measurement of macrophage migration inhibitory factor (MIF) in serum
Time frame: preaoperativ and Within the first 7 postoperative days
Course of GFR determined with the Cystatin C value in serum
Time frame: preaoperativ and Within the first 7 postoperative days
Course of creatinine value in serum
Time frame: Within the first 7 postoperative days
Urine output within the first 48houres after surgery
Time frame: Within the first 7 postoperative days
If applicable determination of kidney injury molecule-1 (KIM-1)or neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: Within the first 7 postoperative days
Determination of acute kidney failure according to the AKIN classification
Time frame: intraoperative
Doses and concentration of study treatments
Time frame: intraoperative and within the first 7 postoperative days
The peri-anaesthetic respiratory profile
Time frame: intraoperative and within the first 7 postoperative days
The peri-anaesthetic haemodynamic profile
Time frame: intraoperative
Intra-operative blood loss
Time frame: intraoperative and within the first 7 postoperative days
The incidence of adverse event (AE) and serious adverse event (SAE)
RWTH Aachen University
Other
Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study
Acronym: PaNeX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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