PaNeX: Partial Nephrectomy Under Xenon

RWTH Aachen University

Status and phase: Completed; Phase 3

Conditions: Renal Function After Partial Nephrectomy

Treatments: Drug: Isoflurane; Drug: Xenon

Study type: Interventional

Funder types: Other

Identifiers

NCT01839084

2012-005698-30 (EudraCT Number)

12-051

Details and patient eligibility

About

Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

Xenon

Experimental group

Description:

Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery

Treatment:

Drug: Xenon

Isoflurane

Active Comparator group

Description:

Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery

Treatment:

Drug: Isoflurane