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

Phase 1

• Conditions: PATIENTS UNDERGOING CORONARY ARTERY BYOASS GRAFT SURGERY; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-005533-20-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-27
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2500

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

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified