Impact of an anaesthesia which is conducted with Xenon on the renal function after removing the broken part of a kidney

Phase 1

• Conditions: renal function after partial nephrectomy; MedDRA version: 14.1Level: LLTClassification code 10034072Term: Partial nephrectomySystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-005698-30-DE
• Lead Sponsor: Clinical Trial Center Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-29
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- signed informed consent
- renal carcinoma
- planned surgery: partial nephrectomy
- male or female patients aged > 18 years old
- ability to understand and to follow the instructions of the staff
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- renal failure with a glomerular filtration rate < 60 ml/min/1,73 m² body surface
- American Society of Anesthesiologists (ASA) Status > III
- known contra-indications and allergies against Propofol, Sufentanil, Xenon, Isoflurane or Rocuronium
- severe cardiac disorder (New York Heart Association NYHA IV), acute coronary syndrome during the last 24h, hemodynamic instability, need for an inotropic support
- severe lung and pulmonary deseases (FeV1/FVC < 70% and FeV1 < 30% of the desired value), or severe chronic respiratory insufficiency with PaO2 <60mmHg, or home based oxygen therapy
- severe neurological disorders
- increase intracranial pressure
- disposition to malignant hyperthermia
- pregnant or breast feeding women
- unability to give consent
- patients who disagree with the conduct of the study
- participation in further trials during the last 30 days
- problems concerning the language and the communication during the consent dialogue
- persons who are accomondated in an institution because of court injunction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified