Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294163
• Other study ID #: ALMED-09-C3-026
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2011
• Last updated: December 18, 2015
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Institute of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery
• Coronary Artery Disease
• Coronary Disease
• General Anesthetic Drug Allergy
• Myocardial Ischemia

Intervention

Drug:
• Xenon
Inhaled xenon, maximal inspired concentration of 65%.
• Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
• Propofol
Hourly dose of 2-4 mg/kg

Locations

Country	Name	City	State
France	Hôpital Cardiovasculaire et Pneumologique Louis Pradel	Bron
France	CHU de Caen	Caen
France	Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes	Nantes
France	Centre Hospitalo-Universitaire Pitié-Salpetrière	Paris
France	Hôpital du Haut-Lévêque	Pessac
France	Hôpital Pontchaillou	Rennes
France	Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil	Strasbourg
France	Centre Hospitalier de Rangueil	Toulouse
Germany	University Hospital Aachen	Aachen
Germany	Klinikum Links der Weser - Senator-Wessling-Str. 1	Bremen
Germany	University Hospital Frankfurt AM Main	Frankfurt
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	UniversitatsKlinikum Schleswig-Holstein	Lubeck
Germany	University Hospital ROSTOCK	Rostock
Italy	Policlinico Umberto I	Rome
Netherlands	Academic Medical Center - University of Amsterdam	Amsterdam
Netherlands	Thorax Center - Erasmus MC	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Level of Troponin I	Blood level of troponin I measured by a central laboratory	Sampling performed 24 hours after the end of the surgical procedure	No
Primary	Log-transformed Blood Level of Troponin I	Blood level of troponin I measured by a central laboratory	Sampling performed 24 hours after the end of the surgical procedure	No
Secondary	Depth of Anaesthesia	On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)	4 hours	No
Secondary	Arterial Oxygen Saturation	Arterial blood gases	4 hours	No
Secondary	Haemodynamic Profile	Monitoring of heart rate, arterial blood pressure, central venous pressure.	4 hours	No
Secondary	Presence or Absence of Postoperative Delirium	Confusion Assessment Method	7 days	No
Secondary	Clinical Laboratory Tests		7 days	Yes
Secondary	ECG Abnormalities		7 days	Yes
Secondary	Vital Signs		7 days	Yes
Secondary	Presence of Absence of Adverse Events, Including Myocardial Infarction		7 days	Yes