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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005698-30 | EudraCT Number |
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon | Experimental | Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery |
|
| Isoflurane | Active Comparator | Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | general anaesthesia with xenon 60% in oxygen (FiO2=0.4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within the first 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. | Ischaemia time | Intraoperatively |
| Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Fahlenkamp, Dr. med. | Department of Anesthesiology, University Hospital Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, University Hospital Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31288740 | Derived | Schafer P, Fahlenkamp A, Rossaint R, Coburn M, Kowark A. Better haemodynamic stability under xenon anaesthesia than under isoflurane anaesthesia during partial nephrectomy - a secondary analysis of a randomised controlled trial. BMC Anesthesiol. 2019 Jul 9;19(1):125. doi: 10.1186/s12871-019-0799-2. | |
| 28719609 | Derived |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D007530 | Isoflurane |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D008738 |
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| Isoflurane | Drug | general anesthesia with isoflurane 1.2% in 40% oxygen/medical air |
|
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Duration of xenon/isoflurane exposition before and after the kidney ischemia time.
| 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 | Intraoperatively until discharge from hospital |
| Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. | Measurement of macrophage migration inhibitory factor (MIF) in serum | 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 | preaoperativ and Within the first 7 postoperative days |
| Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy. | Course of creatinine value in serum | 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 | 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) | 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 | Within the first 7 postoperative days |
| Safety criteria for using xenon-anaesthesia during partial nephrectomy. | Doses and concentration of study treatments | intraoperative |
| Safety criteria for using xenon-anaesthesia during partial nephrectomy. | The peri-anaesthetic respiratory profile | intraoperative and within the first 7 postoperative days |
| Safety criteria for using xenon-anaesthesia during partial nephrectomy. | The peri-anaesthetic haemodynamic profile | intraoperative and within the first 7 postoperative days |
| Safety criteria for using xenon-anaesthesia during partial nephrectomy. | Intra-operative blood loss | intraoperative |
| Safety criteria for using xenon-anaesthesia during partial nephrectomy. | The incidence of adverse event (AE) and serious adverse event (SAE) | intraoperative and within the first 7 postoperative days |
| Stevanovic A, Schaefer P, Coburn M, Rossaint R, Stoppe C, Boor P, Pfister D, Heidenreich A, Christ H, Hellmich M, Fahlenkamp AV. Renal function following xenon anesthesia for partial nephrectomy-An explorative analysis of a randomized controlled study. PLoS One. 2017 Jul 18;12(7):e0181022. doi: 10.1371/journal.pone.0181022. eCollection 2017. |
| Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |