Volatile anesthetics to reduce mortality in cardiac surgery. A multicentre randomized controlled study.

Volatile anesthetics to reduce mortality in cardiac surgery. A multicentre randomized controlled study. - Volatile anesthetics to reduce mortality in cardiac surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005533-20-BE

Enrollment

5200

Registered

2016-01-22

Start date

2016-02-18

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery bypass grafting surgery (CABG).

Interventions

Trade Name: SEVORANE 100%, vloeistof voor inhalatiedamp Pharmaceutical Form: Inhalation solution INN or Proposed INN: SEVOFLURANE CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -age >18 years -written informed consent -scheduled procedures -planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10600 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -pregnancy -planned valve surgery or surgery on the aorta -planned locoregional anesthesia without general anesthesia -unstable or ongoing angina -recent (< 1 month) or ongoing acute myocardial infarction -use of sulfonylurea, theophylline or allopurinol -previous unusual response to an anesthetic agent -inclusion in other randomised controlled studies in the previous 30 days -any general anesthesia performed in the previous 30 days -emergency operation (not scheduled) -kidney or liver transplant in medical history -liver cirrhosis (Child B or C) -patients with absolute contraindications to anesthetic agents as per summary of product characteristics

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare mortality and adverse effects rates after randomisation between inhalation anaesthesia and/or intravenous anaesthesia.;Secondary Objective: Not applicable;Primary end point(s): The primary end point of the study will be 1 year mortality (any cause).;Timepoint(s) of evaluation of this end point: 1 year after anaesthesia.	—

Secondary

Measure	Time frame
Secondary end point(s): - 30 days mortality (any cause). -30 days death or non-fatal myocardial infarction (composite endpoint) -cardiac mortality at 30 days and at 1 year -hospital readmission during the 1 year follow up period -ICU and hospital stay.;Timepoint(s) of evaluation of this end point: 30 days and 1 year after anaesthesia.	—

Countries

Bahrain, Belarus, Belgium, Brazil, China, Colombia, Egypt, Georgia, Iran, Islamic Republic of, Italy, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Switzerland, Thailand, Turkey

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026