Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

NCT05997303 | Completed

• 1 other identifier: 2023-101053-BO-ff
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Perioperative Hypotension

Keywords

blood pressure stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Cumulative dose of norepinephrine

  Measurement period of 15 minutes starting at the beginning of the anesthetic induction

Other Outcomes (5)

• Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index

  Measurement period of 15 minutes starting at the beginning of the anesthetic induction

• Explorative aim - effect on (advanced) hemodynamic variables - heart rate

  Measurement period of 15 minutes starting at the beginning of the anesthetic induction

• Explorative aim - effect on (advanced) hemodynamic variables - cardiac index

  Measurement period of 15 minutes starting at the beginning of the anesthetic induction

Study Arms (2)

Continuous norepinephrine administration

OTHER

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

Manual bolus norepinephrine administration

OTHER

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

Other: Manual bolus norepinephrine administration

Interventions

Continuous norepinephrine infusion via an infusion pump 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.

Continuous norepinephrine administration

Manual bolus norepinephrine administration 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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (1)

• Vokuhl C, Kouz K, Flick M, Krause L, Kroker A, Moll-Khosrawi P, Zollner C, Sessler DI, Saugel B, Thomsen KK. Continuous versus bolus norepinephrine administration and arterial blood pressure stability during induction of general anaesthesia in high-risk noncardiac surgery patients: a randomised trial. Br J Anaesth. 2025 Oct;135(4):878-885. doi: 10.1016/j.bja.2025.06.025. Epub 2025 Jul 30.

  PMID: 40744797 DERIVED

Study Officials

• Christina Vokuhl, M.D.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 18, 2023
• Study Start: September 8, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)