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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01285271
Other study ID # 10-017
Secondary ID 2010-023942-63
Status Completed
Phase Phase 3
First received January 24, 2011
Last updated October 5, 2011
Start date May 2011
Est. completion date September 2011

Study information

Verified date October 2011
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.


Description:

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 anaesthesia for CABG surgery 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 CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Patients with coronary artery disease scheduled for elective CABG

- Patients willing and able to complete the requirements of this study

- Ejection Fraction > 50%

- EuroSCORE = 8

- men and women >= 50 yrs

- women without childbearing potential

- ASA Score II-IV

Exclusion Criteria:

- Lack of informed consent

- EuroSCORE < 8

- MMSE < 24

- Age < 50 years

- COPD GOLD > II, increased need of oxygen

- Renal dysfunction

- Liver function disorders

- Acute coronary syndrome during the last 24 hours; hemodynamic instability

- Requirement of inotropic support

- Off-pump-surgery

- Disabling neuropsychiatric disorders

- History of stroke with residuals

- Hypersensitivity to the study anaesthetics

- Increased intracranial pressure

- Pregnancy and lactation period

- Women of childbearing potential

- Presumed uncooperativeness or legal incapacity

- Participation in a concomitant trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Xenon
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
Sevoflurane
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation

Locations

Country Name City State
Germany Department of Anesthesiology, University Hospital Aachen Aachen NRW

Sponsors (2)

Lead Sponsor Collaborator
RWTH Aachen University German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation The feasibility of xenon application compared to sevoflurane application will be assessed by:
The depth of anaesthesia level
The peri-anaesthetic respiratory profile
The peri-anaesthetic haemodynamic profile
The following safety parameters will be assessed:
Doses and concentration of study treatments
Trans-esophageal echocardiography
Measures of renal function
Intra-operative blood loss and amount of transfused blood/products
Need for hemodynamic and inotropic support
The patient's regional cerebral tissue oxygenation rSO2
The incidence of AE and SAE
an average of 4 to 6 hours Yes
Secondary Secondary efficacy and safety criteria The following secondary efficacy parameters will be assessed:
the patients organ function status
The severity of postoperative critical illness
The incidence of Post-operative Delirium (POD)
The duration of postoperative intensive care unit and in-hospital stay
Secondary safety parameters:
hemodynamic and respiratory profile, including vital signs
incidence of major adverse cardiac and cerebral events (MACCE)
laboratory parameters -post-operative pain
further AE and SAE
6 days Yes
Secondary all cause mortality and contentment questioning Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination. 1 year No
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