Completed

PaNeXImpact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study

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What is being tested

Xenon

+ Isoflurane

Drug
Who is being recruted

Pathologic Processes+2

+ Respiration Disorders

+ Respiratory Tract Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorRWTH Aachen University
Last updated: February 18, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01839084
Principal SponsorRWTH Aachen University
Last updated: February 18, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesRespiration DisordersRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsRespiratory Aspiration

Criteria

5 inclusion criteria required to participate
Informed consent
Men and women >= 18 yrs
Patients undergoing partial nephrectomy
Patients willing and able to complete the requirements of this study
Show More Criteria
13 exclusion criteria prevent from participating
Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
American Society of Anesthesiologists (ASA) > III
Chronic obstructive pulmonary disease (COPD) GOLD IV
Chronic renal failure with a GFR < 60ml/min/1,73m2 body surface area
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Anesthesiology, University Hospital Aachen

Aachen, GermanyOpen Department of Anesthesiology, University Hospital Aachen in Google Maps
CompletedOne Study Center