About this trial
Limiting perioperative tachycardia (aiming for a heart rate \<90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective non-cardiac surgery defined as intermediate or high-risk by the 2022 european society of cardiology (ESC) guidelines
surgery performed under general anesthesia;
expected length of hospital stay ≥ 24 hours;
age ≥ 45 years;
Disqualifiers
unable to consent or follow study procedures;
absolute contraindications for exercise testing;
pregnancy or intention to become pregnant;
active cardiac conditions (such as unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease);
Trial design
Parallel
Treatments tested in this trial
Landiolol
DrugThe main dose range is 1-40 mcg/kg/min, titrated to the effect on heart rate aiming for a heart rate of below 90 beats per minute throughout. This dose can be decreased to 0 if heart rate stays below target.
Treatment groups
Trial outcomes
Primary outcomes
Time perioperative heart rate in target range
As a marker of successful intervention, time perioperative heart rate in target range (below 90 beats per minute) will serve as primary outcome. The intervention is considered feasible if the heart rate stays at least 90% of the time within the target range during the perioperative period.
Secondary outcomes
Perioperative heart rate
Perioprative heart rate will be calculated as time weighted area under the curve for the perioperative period.
Dose of vasopressors
Total dose of vasopressors such as noradrenalin, ephedrine or phenylephrine will be recorded in micrograms.
Length of postanaesthetic care unit stay
Lenght of postaenaesthetic care unit stay will be recorded in minutes.
Length of hospital stay
Length of hospital stay will be recorded in days.
Other outcomes
Major adverse cardio- and cerebrovascular events
Major adverse cardio- and cerebrovascular events (MACCE) include diagnosis of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia or angina, non-fatal stroke.
All-cause death
This parameter serves to assess postoperative mortality.
Quality of life (EQ-5D)
Quality of life will be assessed using the EQ-5D questionnaire. The EQ-5D questionnaire is a standardised health-related quality of life questionnaire developed by the EuroQol Group. It assesses five dimensions of health and results in an utility index score ranging from 0 (death) to 1 (perfect health).
Comprehensive complication index
The comprehensive complication index is calculated as a sum of all complications weighted for their severity. It results in a continuous scale ranking the severity of any combination of complications from 0 (no complication) to 100 (death).
Sponsors and contacts
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