Patients undergoing elective or urgent non-cardiac surgery requiring general and/or regional anaesthesia with sedation Surgery
Conditions
Interventions
Following provision of informed consent, participants will be centrally allocated to one of two treatment groups in a 1:1 ratio by minimisation with a random component. Minimisation variables are (1)
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
55 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria of as 07/03/2023: 1. Patients aged 55 years and over 2. Undergoing elective or urgent non-cardiac surgery requiring general and/or regional anaesthesia with sedation, expected to take longer than 120 minutes from the induction of anaesthesia 3. At least one medical risk factor for perioperative myocardial injury 4. History of hypertension (requiring anti-hypertensive drug) or hypertension recorded in the pre-assessment clinic [BP>140mmHg systolic; >90 mmHg diastolic] Previous participant inclusion criteria: 1. Patients aged 55 years and over 2. Undergoing elective or urgent non-cardiac surgery requiring general and/or regional anaesthesia with sedation, expected to take longer than 120 minutes from the induction of anaesthesia 3. At least one medical risk factor for perioperative myocardial injury
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria of as 07/03/2023: 1. Inability or refusal to provide informed consent 2. Patients lacking capacity 3. Prior use of ivabradine within the previous 30 days 4. Current participation in a clinical trial of a treatment with a similar biological mechanism 5. Previous enrolment into FUNNY trial 6. Contraindication to ivabradine 7. History of hypersensitivity or allergy to ivabradine or any of its excipients 8. Women of childbearing potential (this includes pregnancy and lactation). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant unless permanently sterile 9. Patients with atrial fibrillation (persistent/chronic or paroxysmal) Previous participant exclusion criteria: 1. Inability or refusal to provide informed consent 2. Patients lacking capacity 3. Prior use of ivabradine within the previous 30 days 4. Current participation in a clinical trial of a treatment with a similar biological mechanism 5. Previous enrolment into FUNNY trial 6. Contraindication to ivabradine 7. History of hypersensitivity or allergy to ivabradine or any of its excipients 8. Women of childbearing potential (this includes pregnancy and lactation). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant unless permanently sterile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite of myocardial injury associated with morbidity within seven days of surgery. To meet the criteria for the primary outcome, the patient must experience the following: 1. Increase in serum high sensitivity troponin-T (Elecsys, Roche Diagnostics) concentration (measured using blood test) of: a. An absolute value of =15ng/L-1 on day one, day two or day three after surgery, OR b. An increase of =5 ng/L-1 from the preoperative value on day one, day two or day three after surgery when the preoperative value was =15ng/L-1, AND 2. Any POMS defined morbidity domain on day three or day seven after surgery measured from patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any POMS defined morbidity domain on day three or seven after surgery measured from patient records 2. Levels of serum high-sensitivity troponin-T (Elecsys, Roche Diagnostics) measured using blood test on day one, day two and day three after surgery 3. Predefined complications at day 30 after surgery graded using the Clavien-Dindo classification measured from patient records | — |
Countries
England, United Kingdom
Contacts
Public ContactTasnin Shahid
Outcome results
None listed