Clinical trial NCT01839084: PaNeX: Partial Nephrectomy Under Xenon
Official title: Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Function After Partial Nephrectomy
Keywords: Xenon
Isoflurane
Anesthetics, Inhalation
Nephroprotection
Partial nephrectomy
Xenon versus Isoflurane anesthesia
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2013-04-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia.
timeFrame: Within the first 7 postoperative days
Secondary outcomes:
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Intraoperatively
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Intraoperatively
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Intraoperatively until discharge from hospital
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Intraoperatively and within the first 7 postoperative days
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: preaoperativ and Within the first 7 postoperative days
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: preaoperativ and Within the first 7 postoperative days
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Within the first 7 postoperative days
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Within the first 7 postoperative days
measure: Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: Within the first 7 postoperative days
measure: Safety criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: intraoperative
measure: Safety criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: intraoperative and within the first 7 postoperative days
measure: Safety criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: intraoperative and within the first 7 postoperative days
measure: Safety criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: intraoperative
measure: Safety criteria for using xenon-anaesthesia during partial nephrectomy.
timeFrame: intraoperative and within the first 7 postoperative days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Anesthesiology, University Hospital Aachen
state: NRW
Study officials:
affiliation: Department of Anesthesiology, University Hospital Aachen
name: Astrid Fahlenkamp, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.