Clinical trial NCT05997303: Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
Official title: Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Perioperative Hypotension
Keywords: blood pressure stability
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 72
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure stability
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Secondary outcomes:
measure: Area under MAP
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Cumulative duration of a MAP below
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Area above MAP
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Cumulative duration of a MAP above
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Cumulative dose of norepinephrine
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Other outcomes:
measure: Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Explorative aim - effect on (advanced) hemodynamic variables - heart rate
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Explorative aim - effect on (advanced) hemodynamic variables - cardiac index
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
measure: Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation
timeFrame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christina Vokuhl, M.D.
role: PRINCIPAL_INVESTIGATOR
References: