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

Phase 3

Completed

• Conditions: Coronary Artery Disease; General Anesthetic Drug Allergy; Coronary Artery Bypass Graft Surgery
• Interventions: Drug: Sevoflurane; Drug: Propofol; Drug: Xenon

• Registration Number: NCT01294163
• Lead Sponsor: Air Liquide Santé International

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Study Start: 2011-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-11-06
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-18
• Last Update Submitted: 2015-12-18
• Results First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	-
Total intravenous anaesthesia	Propofol	-
Xenon	Xenon	-

Primary Outcome Measures

Name	Time	Method
Blood Level of Troponin I	Sampling performed 24 hours after the end of the surgical procedure	Blood level of troponin I measured by a central laboratory
Log-transformed Blood Level of Troponin I	Sampling performed 24 hours after the end of the surgical procedure	Blood level of troponin I measured by a central laboratory

Secondary Outcome Measures

Name	Time	Method
Depth of Anaesthesia	4 hours	On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
Arterial Oxygen Saturation	4 hours	Arterial blood gases
Haemodynamic Profile	4 hours	Monitoring of heart rate, arterial blood pressure, central venous pressure.
Presence or Absence of Postoperative Delirium	7 days	Confusion Assessment Method
Clinical Laboratory Tests	7 days
ECG Abnormalities	7 days
Vital Signs	7 days
Presence of Absence of Adverse Events, Including Myocardial Infarction	7 days

Trial Locations

Locations (17)

Thorax Center - Erasmus MC; 🇳🇱 Rotterdam, Netherlands

University Hospital Aachen; 🇩🇪 Aachen, Germany

Hôpital Pontchaillou; 🇫🇷 Rennes, France

University Hospital Frankfurt AM Main; 🇩🇪 Frankfurt, Germany

Hôpital du Haut-Lévêque; 🇫🇷 Pessac, France

CHU de Caen; 🇫🇷 Caen, France

Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France

UniversitatsKlinikum Schleswig-Holstein; 🇩🇪 Lubeck, Germany

Centre Hospitalo-Universitaire Pitié-Salpetrière; 🇫🇷 Paris, France

Klinikum Links der Weser - Senator-Wessling-Str. 1; 🇩🇪 Bremen, Germany

Hôpital Cardiovasculaire et Pneumologique Louis Pradel; 🇫🇷 Bron, France

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Academic Medical Center - University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Policlinico Umberto I; 🇮🇹 Rome, Italy

Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

University Hospital ROSTOCK; 🇩🇪 Rostock, Germany

Centre Hospitalier de Rangueil; 🇫🇷 Toulouse, France