Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Perioperative Hypotension
• Intervention / Treatment: Other: Continuous norepinephrine infusion via an infusion pump; Other: Manual bolus norepinephrine administration

Detailed Description

not provided

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index	We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on stroke volume index [ml/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).	Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Explorative aim - effect on (advanced) hemodynamic variables - heart rate	We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on heart rate [beats/minute] using invasive uncalibrated pulse wave analysis (MostcareUP System).	Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Explorative aim - effect on (advanced) hemodynamic variables - cardiac index	We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on cardiac index [l/min/m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).	Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index	We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on systemic vascular resistance index [dyn × s × cm^-5 × m^2] using invasive uncalibrated pulse wave analysis (MostcareUP System).	Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation	We aim to investigate the effect of giving norepinephrine continuously via an infusion pump during anesthetic induction on pulse pressure variation [%] using invasive uncalibrated pulse wave analysis (MostcareUP System).	Measurement period of 15 minutes starting at the beginning of the anesthetic induction

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Christina Vokuhl, M.D., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: blood pressure stability
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: 2023-101053-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No