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Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

Primary Purpose

Blood Pressure, Perioperative Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous norepinephrine infusion via an infusion pump
Manual bolus norepinephrine administration
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Pressure focused on measuring blood pressure stability

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Hamburg-EppendorfRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Continuous norepinephrine administration

Manual bolus norepinephrine administration

Arm Description

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

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

Outcomes

Primary Outcome Measures

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].

Secondary Outcome Measures

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

Full Information

First Posted
July 17, 2023
Last Updated
September 24, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT05997303
Brief Title
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
Official Title
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Perioperative Hypotension
Keywords
blood pressure stability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous norepinephrine administration
Arm Type
Other
Arm Description
continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists
Arm Title
Manual bolus norepinephrine administration
Arm Type
Other
Arm Description
manual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists
Intervention Type
Other
Intervention Name(s)
Continuous norepinephrine infusion via an infusion pump
Intervention Description
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
Intervention Name(s)
Manual bolus norepinephrine administration
Intervention Description
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 Outcome Measure Information:
Title
Blood pressure stability
Description
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].
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Secondary Outcome Measure Information:
Title
Area under MAP
Description
Area under a MAP of 65, 60, 50, and 40 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring.
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Cumulative duration of a MAP below
Description
Cumulative duration of a MAP <65, <60, <50, and <40 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring.
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Area above MAP
Description
Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg × min]. MAP will be measured using intraarterial blood pressure monitoring.
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Cumulative duration of a MAP above
Description
Cumulative duration of a MAP >100, >110, >120, and >140 mmHg [min]. MAP will be measured using intraarterial blood pressure monitoring.
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Cumulative dose of norepinephrine
Description
Cumulative dose of norepinephrine indexed to body weight [μg/kg]
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Other Pre-specified Outcome Measures:
Title
Explorative aim - effect on (advanced) hemodynamic variables - stroke volume index
Description
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).
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Explorative aim - effect on (advanced) hemodynamic variables - heart rate
Description
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).
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Explorative aim - effect on (advanced) hemodynamic variables - cardiac index
Description
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).
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Explorative aim - effect on (advanced) hemodynamic variables - systemic vascular resistance index
Description
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).
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Title
Explorative aim - effect on (advanced) hemodynamic variables - pulse pressure variation
Description
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).
Time Frame
Measurement period of 15 minutes starting at the beginning of the anesthetic induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Vokuhl, M.D.
Phone
+49 15222827456
Email
c.vokuhl@uke.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Vokuhl, M.D.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Vokuhl, M.D.
Email
c.vokuhl@uke.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction

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