Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-04-19

Brief Summary

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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.

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Detailed Description

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not provided

Conditions

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Blood Pressure Perioperative Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Continuous norepinephrine administration

continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists

Group Type OTHER

Continuous norepinephrine infusion via an infusion pump

Intervention Type OTHER

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

manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists

Group Type OTHER

Manual bolus norepinephrine administration

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No