Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

Blood Pressure Clinical Trial

Official title:

Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997303
• Other study ID #: 2023-101053-BO-ff
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Christina Vokuhl, M.D.
• Phone: +49 15222827456
• Email: c.vokuhl[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

not provided

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypotension
• Perioperative Hypotension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	Cumulative duration of a MAP below	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
Secondary	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
Secondary	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
Secondary	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