We’re planning a large multicentre controlled randomized trial to demonstrate that volatile anesthetics vs TIVA can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass) and 30 days after surgery (co-primary endpoint) in patients undergoing coronary artery bypass grafting

VOLATILE ANESTHETICS TO REDUCE MORTALITY IN CARDIAC SURGERY. A MULTICENTRE RANDOMIZED CONTROLLER STUDY - VOLATILE 10600

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005533-20-IT

Enrollment

2500

Registered

2014-01-27

Start date

2014-12-11

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

PATIENTS UNDERGOING CORONARY ARTERY BYOASS GRAFT SURGERY

Interventions

Trade Name: SEVOFLURANE Pharmaceutical Form: Inhalation solution Trade Name: DESFLURANE Pharmaceutical Form: Inhalation solution Trade Name: ISOFLURANE Pharmaceutical Form: Inhalation solution

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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduce 1 year mortality from 3% to 2% in patients undergoing CABG;Secondary Objective: Reduce 30 days mortality;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	—

Secondary

Measure	Time frame
Secondary end point(s): cardiac mortality at 30 days and at 1 year - rehospitalization during follow up period - intensive care unit stay and hospital stay;Timepoint(s) of evaluation of this end point: 30 days and 1 year	—

Countries

Belgium, Italy

Contacts

Public ContactANESTESIA E RIANIMAZIONE CARDIOCHIR

OSPEDALE SAN RAFFAELE IRCCS

landoni.giovanni@hsr.it+390226437154

Outcome results

None listed

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