Trial record 9 of 156 for:
Open Studies | "Coronary Artery Bypass"
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
This study is currently recruiting participants.
Verified May 2013 by Air Liquide Santé International
Sponsor:
Air Liquide Santé International
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01294163
First received: February 9, 2011
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.
This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.
The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease General Anesthetic Drug Allergy Coronary Artery Bypass Graft Surgery |
Drug: Xenon Drug: Sevoflurane Drug: Propofol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Xenon Anaesthesia Compared to Sevoflurane Anaesthesia and Total Intravenous Anaesthesia for On-pump Coronary Artery Bypass Graft Surgery: a Randomised, Three-arm, Single-blind, International Study |
Resource links provided by NLM:
MedlinePlus related topics:
Allergy
Coronary Artery Bypass Surgery
Coronary Artery Disease
Drug Reactions
Heart Attack
U.S. FDA Resources
Further study details as provided by Air Liquide Santé International:
Primary Outcome Measures:
- Blood level of troponin I [ Time Frame: 1 day ] [ Designated as safety issue: No ]Troponin I, sampling performed 24 hours after the end of the surgical procedure and measured by a central laboratory.
Secondary Outcome Measures:
- Depth of anaesthesia [ Time Frame: 4 hours ] [ Designated as safety issue: No ]On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
- Arterial oxygen saturation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Arterial blood gases
- Haemodynamic profile [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Monitoring of heart rate, arterial blood pressure, central venous pressure.
- Presence or absence of postoperative delirium [ Time Frame: 7 days ] [ Designated as safety issue: No ]Confusion Assessment Method
- Clinical laboratory tests [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- ECG abnormalities [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Presence of absence of adverse events, including myocardial infarction [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 492 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Xenon |
Drug: Xenon
Inhaled xenon, maximal inspired concentration of 65%.
Other Name: Xenon
|
| Active Comparator: Sevoflurane |
Drug: Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
Other Name: Sevoflurane
|
| Active Comparator: Total intravenous anaesthesia |
Drug: Propofol
Hourly dose of 2-4 mg/kg
Other Name: Propofol
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- coronary artery disease
- elective surgery, planned coronary artery bypass graft
- moderate hypothermia or normothermia
- cardiac arrest cold and warm cardioplegia
- normal of moderately impaired left ventricular systolic function
- written informed consent
Exclusion Criteria:
- pregnancy or child bearing potential
- ongoing treatment with nicorandil or sulfonylurea medication
- severe renal or hepatic dysfunction
- ongoing myocardial infarction or unstable angina
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294163
Contacts
| Contact: Jean HAZEBROUCQ, MD | +33139076426 | jean.hazebroucq@airliquide.com |
Locations
| France | |
| Hôpital Cardiovasculaire et Pneumologique Louis Pradel | Recruiting |
| Bron, France, 69677 | |
| Contact: Olivier J BASTIEN, Prof +33472118933 olivier.bastien@chu-lyon.fr | |
| Principal Investigator: Jean J LEHOT, Prof | |
| Centre Hospitalo-Universitaire Pitié-Salpetrière | Recruiting |
| Paris, France, 75013 | |
| Contact: Julien AMOUR, Professeur +33 1 42 16 56 41 julien.amour@psl.aphp.fr | |
| Principal Investigator: Julien AMOUR, Prof. | |
| Hôpital du Haut-Lévêque | Recruiting |
| Pessac, France, 33600 | |
| Contact: Alexandre OUATTARA, Professor (33) 05 57 65 68 68 alexandre.ouattara@chu-bordeaux.fr | |
| Principal Investigator: Alexandre OUATTARA, Professor | |
| Hôpital Pontchaillou | Recruiting |
| Rennes, France, 35033 | |
| Contact: Claude ECOFFEY, Prof +33299282422 claude.ecoffey@chu-rennes.fr | |
| Principal Investigator: Claude ECOFFEY, Prof | |
| Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Annick STEIB, Prof +33369551091 Annick.Steib@chru-strasbourg.fr | |
| Principal Investigator: Annick STEIB, Prof | |
| Centre Hospitalier de Rangueil | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Hamina BENHAOUA, MD +33561325651 benhaoua.h@chu-toulouse.fr | |
| Principal Investigator: Hamina BENHAOUA, MD | |
| Germany | |
| Universitätsklinikum Schleswig-Holstein | Recruiting |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| Contact: Berthold BEIN, Prof. +49 431 597-3739 bein@anaesthesie.uni-kiel.de | |
| Principal Investigator: Berthold BEIN, Prof. | |
| University Hospital Aachen | Recruiting |
| Aachen, Germany, 52074 | |
| Contact: Rolf ROSSAINT, Professor +442418088179 anaesthesiologie@ukaachen.de | |
| Sub-Investigator: Mark COBURN, PD, MD | |
| Klinikum Links der Weser - Senator-Wessling-Str. 1 | Recruiting |
| Bremen, Germany, 28277 | |
| Contact: Peter TONER, Professor +49 (0421) 879-1730 Peter.Tonner@klinikum-bremen-ldw.de | |
| Principal Investigator: Peter TONER, Professor | |
| UniversitatsKlinikum Schleswig-Holstein | Recruiting |
| Lubeck, Germany, 23538 | |
| Contact: Matthias HERINGLAKE, Prof. +494515002772 Heringlake@t-online.de | |
| Principal Investigator: Matthias HERINGLAKE, Prof. | |
| Italy | |
| Policlinico Umberto I | Not yet recruiting |
| Rome, Italy, 00161 | |
| Contact: Luigi TRITAPEPE, Professor +390649972695 luigi.tritapepe@uniroma1.it | |
| Principal Investigator: Luigi TRITAPEPE, Professor | |
| Netherlands | |
| Academic Medical Center - University of Amsterdam | Recruiting |
| Amsterdam, Netherlands, 1100 DD | |
| Contact: Benedikt PRECKEL, MD +3120 56 62 162 | |
| Principal Investigator: Benedikt PRECKEL, MD | |
| Thorax Center - Erasmus MC | Recruiting |
| Rotterdam, Netherlands, 3000 CA | |
| Contact: Jan HOFLAND, MD +31107036212 j.hofland.1@erasmusmc.nl | |
| Principal Investigator: Jan HOFLAND, MD | |
Sponsors and Collaborators
Air Liquide Santé International
Orion Corporation, Orion Pharma
Investigators
| Principal Investigator: | Jan HOFLAND, MD, PhD | Thorax Centre Erasmus MC, Rotterdam, the Netherlands |
More Information
No publications provided
| Responsible Party: | Air Liquide Santé International |
| ClinicalTrials.gov Identifier: | NCT01294163 History of Changes |
| Other Study ID Numbers: | ALMED-09-C3-026 |
| Study First Received: | February 9, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: National Institute of Health Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Air Liquide Santé International:
|
Xenon Sevoflurane Propofol Total intravenous anaesthesia |
Anaesthesia Coronary artery disease Coronary artery bypass graft |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Drug Hypersensitivity Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hypersensitivity Immune System Diseases Anesthetics Propofol |
Xenon Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives Anesthetics, Inhalation Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013