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This is a randomized trial investigating whether continuous norepinephrine administration via an infusion pump - compared to manual bolus administration - increases blood pressure stability within the first 15 minutes of anesthetic induction in non-cardiac surgery patients.
The secondary endpoints area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min], cumulative duration of a MAP <65, <60, <50, and <40 mmHg [min], area above a MAP of 100, 110, 120, and 140 mmHg [mmHg min], cumulative duration of a MAP >100, >110, >120, and >140 mmHg [min] and cumulative dose of norepinephrine indexed to body weight [μg/kg] within the first 15 minutes of anesthetic induction will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous norepinephrine administration | Other | continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists |
|
| Manual bolus norepinephrine administration | Other | manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous norepinephrine infusion via an infusion pump | Other | Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure stability | Generalized average real variability (gARV) of mean arterial pressure (MAP) within the first 15 minutes of anesthetic induction [mmHg/min]; the gARV is the sum of absolute values of the differences between neighboring measurements for all measurements divided by the total measurement duration in [mmHg/min]. | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Measure | Description | Time Frame |
|---|---|---|
| Area under MAP | Area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring. | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Cumulative duration of a MAP below |
| Measure | Description | Time Frame |
|---|---|---|
| Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index | We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on stroke volume index [ml/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System). | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Vokuhl, M.D. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20251 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40744797 | Derived | Vokuhl C, Kouz K, Flick M, Krause L, Kroker A, Moll-Khosrawi P, Zollner C, Sessler DI, Saugel B, Thomsen KK. Continuous versus bolus norepinephrine administration and arterial blood pressure stability during induction of general anaesthesia in high-risk noncardiac surgery patients: a randomised trial. Br J Anaesth. 2025 Oct;135(4):878-885. doi: 10.1016/j.bja.2025.06.025. Epub 2025 Jul 30. |
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|
| Manual bolus norepinephrine administration | Other | Patients will be randomized 1:1 to continuous norepinephrine infusion via an infusion pump or to manual bolus norepinephrine administration. The norepinephrine dose will be at the discretion of the treating anesthesiologists. |
|
Cumulative duration of a MAP <65, <60, <50, and <40 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring. |
| Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Area above MAP | Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring. | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Cumulative duration of a MAP above | Cumulative duration of a MAP >100, >110, >120, and >140 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring. | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Cumulative dose of norepinephrine | Cumulative dose of norepinephrine indexed to body weight [μg/kg] | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Explorative aim - effect on (advanced) hemodynamic variables - heart rate | We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on heart rate [beats/minute] using invasive uncalibrated pulse wave analysis (MostcareUP System). | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Explorative aim - effect on (advanced) hemodynamic variables - cardiac index | We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on cardiac index [l/min/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System). | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index | We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on systemic vascular resistance index [dyn × s × cm^-5 × m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System). | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |
| Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation | We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on pulse pressure variation [%] using invasive uncalibrated pulse wave analysis (MostcareUP System). | Measurement period of 15 minutes starting at the beginning of the anesthetic induction |