Phase 3 N=600 Randomized Single-blind Screening

Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery

Elevated Cardiac Risk · Coronary Arteries Disease Risk

Bottom Line

View on ClinicalTrials.gov: NCT01120405 ↗

Enrolled (actual)

600

Serious AEs

5.8%

Results posted

Jun 2014

Primary outcome: Primary: Number of Participants With Myocardial Necrosis (MN) — 57; 54 participants — p=0.0052

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Xenon (Drug); Sevoflurane (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Air Liquide Santé International
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Myocardial Necrosis (MN)	57; 54	0.0052 sig
SECONDARY Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)	27; 25	0.7715
SECONDARY Number of Participants With Myocardial Infarction (MI)	5; 3	0.4763
SECONDARY Number of Participants With Cerebro-Vascular Event	2; 3	0.6533
SECONDARY Number of Participants With Life-Threatening Arrhythmia	2; 0	0.1559
SECONDARY Number of Participants Who Died From Cardiac Origin	0; 0	—
SECONDARY Number of Participants With Composite Endpoint	61; 56	0.6056
SECONDARY Systolic Blood Pressure (SBP)	146.1; 147.3; 90.6; 90.3; 94.8; 83.8	—
SECONDARY Vital Signs (SBP and DBP Changes)	-12.2; -14.2; -10.8; -10.7; -11.9; -12.2	—
SECONDARY Vital Signs (Heart Rate Changes)	6.35; 6.35; 8.81; 9.85; 6.44; 8.90	—
SECONDARY Number of Participants With Chest Pain During the 3 Postoperative Days	0; 0; 0; 2; 1; 2	—
SECONDARY Urine Output	1279.0; 1324.4	—

Summary

The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years
Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
Cardiac ischaemic risk supported by:
History of myocardial infarction older than 1 month and/or
Documented Stable angina (asymptomatic ± medical treatment) and/or
History of coronary revascularisation, and/or
Surgical Risk Index ("Lee" index) ≥ 3.
Written informed consent

Exclusion Criteria

Unstable angina within the last 30 days,
Non controlled arterial Hypertension .
Severe Cardiac heart Failure (NYHA IV)
Severe Chronic Obstructive Pulmonary Disease
Patient already randomized in another ongoing clinical trial
Patient with recent myocardial infarction (M.I) (less than one month )
Patient already included in a clinical trial
History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)
Malignant hyperthermia
Documented Elevated intracranial pressure
Preeclampsia or eclampsia
Pregnancy and lactation
Presumed uncooperativeness or legal incapacity

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01120405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.