Blood Pressure, Perioperative Hypotension
Conditions
Keywords
blood pressure stability
Brief summary
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.
Detailed description
not provided
Interventions
OTHERContinuous norepinephrine infusion via an infusion pump
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.
OTHERManual bolus norepinephrine administration
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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 45 years * American Society of Anesthesiologists physical status II-IV * scheduled for elective major non-cardiac surgery under general anesthesia * continuous intraarterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the trial * sinus rhythm
Exclusion criteria
* Clinical indication to use a continuous norepinephrine infusion via an infusion pump during anesthetic induction * Need for femoral artery catheterization * History of intracranial bleedings or aneurysms * Patients who are incapable of giving consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure stability | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | 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 \[mmHg/min\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under MAP | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | Area under a MAP of 65, 60, 50, and 40 mmHg \[mmHg × min\]. MAP will be measured using intraarterial blood pressure monitoring. |
| Cumulative duration of a MAP below | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | Cumulative duration of a MAP \<65, \<60, \<50, and \<40 mmHg \[min\]. MAP will be measured using intraarterial blood pressure monitoring. |
| Area above MAP | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | Area above a MAP of 100, 110, 120, and 140 mmHg \[mmHg × min\]. MAP will be measured using intraarterial blood pressure monitoring. |
| Cumulative duration of a MAP above | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | Cumulative duration of a MAP \>100, \>110, \>120, and \>140 mmHg \[min\]. MAP will be measured using intraarterial blood pressure monitoring. |
| Cumulative dose of norepinephrine | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | Cumulative dose of norepinephrine indexed to body weight \[μg/kg\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Explorative aim - effect on (advanced) hemodynamic variables - heart rate | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | 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). |
| Explorative aim - effect on (advanced) hemodynamic variables - cardiac index | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | 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). |
| Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | 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). |
| Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | 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). |
| Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index | Measurement period of 15 minutes starting at the beginning of the anesthetic induction | 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). |
Countries
Germany
Outcome results
None listed