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NCT Number: NCT05997303

Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

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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Key information

Conditions

Blood Pressure Perioperative Hypotension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

About this study

not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Area under MAP

    Time frame: 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.

  2. Cumulative duration of a MAP below

    Time frame: 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.

  3. Area above MAP

    Time frame: 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.

  4. Cumulative duration of a MAP above

    Time frame: 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.

  5. Cumulative dose of norepinephrine

    Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction

    Cumulative dose of norepinephrine indexed to body weight [μg/kg]

Other outcomes

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

    Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction

    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).

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

    Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction

    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).

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

    Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction

    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).

  4. Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index

    Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction

    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).

  5. Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation

    Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction

    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).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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