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

• ClinicalTrials.gov Identifier: NCT01294163
• Recruitment Status: Completed
• First Posted: February 11, 2011
• Results First Posted: December 21, 2015
• Last Update Posted: December 21, 2015
• Sponsor: Air Liquide Santé International
• Collaborator: Orion Corporation, Orion Pharma
• Information provided by (Responsible Party): Air Liquide Santé International

Tracking Information

• First Submitted Date: February 9, 2011
• First Posted Date: February 11, 2011
• Results First Submitted Date: November 6, 2015
• Results First Posted Date: December 21, 2015
• Last Update Posted Date: December 21, 2015
• Study Start Date: April 2011
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2015)

• Blood Level of Troponin I [ Time Frame: 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 [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]
  Blood level of troponin I measured by a central laboratory

Original Primary Outcome Measures (submitted: February 10, 2011)

Blood Level of Troponin I [ Time Frame: 1 day ]

Troponin I, sampling perfomed 24 hours after the end of the surgical procedure and measured by a central laboratory.

Current Secondary Outcome Measures (submitted: February 10, 2011)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
• 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

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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

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

Intervention

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

Study Arms

• Experimental: Xenon
  Intervention: Drug: Xenon
• Active Comparator: Sevoflurane
  Intervention: Drug: Sevoflurane
• Active Comparator: Total intravenous anaesthesia
  Intervention: Drug: Propofol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2014): 509
• Original Estimated Enrollment (submitted: February 10, 2011): 492
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Italy, Netherlands

Administrative Information

• NCT Number: NCT01294163
• Other Study ID Numbers: ALMED-09-C3-026
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Air Liquide Santé International
• Study Sponsor: Air Liquide Santé International
• Collaborators: Orion Corporation, Orion Pharma

Investigators

• Principal Investigator: Jan HOFLAND, MD, PhD; Thorax Centre Erasmus MC, Rotterdam, the Netherlands

• PRS Account: Air Liquide Santé International
• Verification Date: December 2015