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Clinical Trials/NCT05997303
NCT05997303
Completed
Not Applicable

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country72 target enrollmentSeptember 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
72
Locations
1
Primary Endpoint
Blood pressure stability
Status
Completed
Last Updated
last year

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

Registry
clinicaltrials.gov
Start Date
September 8, 2023
End Date
April 19, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Blood pressure stability

Time Frame: 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 Outcomes

  • Area under MAP(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
  • Cumulative duration of a MAP below(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
  • Cumulative dose of norepinephrine(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
  • Area above MAP(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)
  • Cumulative duration of a MAP above(Measurement period of 15 minutes starting at the beginning of the anesthetic induction)

Study Sites (1)

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