Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
not provided
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Continuous norepinephrine administration continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists |
Other: Continuous 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.
|
| Other: Manual bolus norepinephrine administration manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists |
Other: Manual 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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).
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 45 years
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American Society of Anesthesiologists physical status II-IV
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scheduled for elective major non-cardiac surgery under general anesthesia
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continuous intraarterial blood pressure monitoring using a radial arterial catheter for clinical indications not related to the trial
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sinus rhythm
Exclusion Criteria:
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Clinical indication to use a continuous norepinephrine infusion via an infusion pump during anesthetic induction
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Need for femoral artery catheterization
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History of intracranial bleedings or aneurysms
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Patients who are incapable of giving consent
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20251 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: Christina Vokuhl, M.D., Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-101053-BO-ff