Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

Study Overview
=================
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

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

Conditions
-----------------
Blood Pressure, Perioperative Hypotension

Intervention / Treatment
-----------------
* Other: Continuous norepinephrine infusion via an infusion pump
* Other: Manual bolus norepinephrine administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous norepinephrine administration<br>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<br>* 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.<br>|
| Other: Manual bolus norepinephrine administration<br>manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists | Other: Manual bolus norepinephrine administration<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure stability