Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
46 participants
INTERVENTIONAL
2013-07-31
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Xenon
Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery
Xenon
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
Isoflurane
Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery
Isoflurane
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Interventions
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Xenon
general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
Isoflurane
general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with renal carcinoma restricted to one kidney
* Patients undergoing partial nephrectomy
* Men and women \>= 18 yrs
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Astrid Fahlenkamp, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, University Hospital Aachen
Locations
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Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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References
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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.
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.
Other Identifiers
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2012-005698-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12-051
Identifier Type: -
Identifier Source: org_study_id
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