Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

Not Applicable

Completed

• Conditions: Perioperative Hypotension; Blood Pressure

• Registration Number: NCT05997303
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-18
• Study Start: 2023-09-08
• Primary Completion: 2024-04-19
• Study Completion: 2024-04-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood pressure stability	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 Outcome Measures

Name	Time	Method
Area under MAP	Measurement period of 15 minutes starting at the beginning of the anesthetic induction	Area under a MAP of 65, 60, 50, and 40 mmHg \[mmHg × min\]. MAP will be measured using intraarterial blood pressure monitoring.
Cumulative duration of a MAP below	Measurement period of 15 minutes starting at the beginning of the anesthetic induction	Cumulative duration of a MAP \<65, \<60, \<50, and \<40 mmHg \[min\]. MAP will be measured using intraarterial blood pressure monitoring.
Cumulative dose of norepinephrine	Measurement period of 15 minutes starting at the beginning of the anesthetic induction	Cumulative dose of norepinephrine indexed to body weight \[μg/kg\]
Area above MAP	Measurement period of 15 minutes starting at the beginning of the anesthetic induction	Area above a MAP of 100, 110, 120, and 140 mmHg \[mmHg × min\]. MAP will be measured using intraarterial blood pressure monitoring.
Cumulative duration of a MAP above	Measurement period of 15 minutes starting at the beginning of the anesthetic induction	Cumulative duration of a MAP \>100, \>110, \>120, and \>140 mmHg \[min\]. MAP will be measured using intraarterial blood pressure monitoring.

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany