Blood PressureNCT05997303
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
A study testing Continuous norepinephrine infusion via an infusion pump and Manual bolus norepinephrine administration in people with Blood Pressure and Perioperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Blood Pressure, Perioperative Hypotension
- What is being tested?
- Continuous norepinephrine infusion via an infusion pump and Manual bolus norepinephrine administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 8 Sep 2023to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
not provided
- Conditions
- Blood Pressure, Perioperative Hypotension
- Being tested
- Continuous norepinephrine infusion via an infusion pump, Manual bolus norepinephrine administration
- Keywords
- blood pressure stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous norepinephrine infusion via an infusion pumpOther
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 administrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous norepinephrine administration | Other | continuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists Receives: 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 Receives: Other: Manual bolus norepinephrine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]
Measured: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start8 Sep 2023
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Vokuhl, M.D., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997303
- Sponsor's protocol ID
- 2023-101053-BO-ff
- Other IDs
- 2023
- Status last verified
- May 2024
- First submitted
- 17 Jul 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40744797
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05997303
- Acronym / sponsor ID
- 2023-101053-BO-ff
- Conditions
- Blood Pressure, Perioperative Hypotension
- Keywords
- blood pressure stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous norepinephrine administration | Other | Other: Continuous norepinephrine infusion via an infusion pumpcontinuous norepinephrine infusion via an infusion pump; norepinephrine dose will be at the discretion of the treating anesthesiologists |
| Manual bolus norepinephrine administration | Other | Other: Manual bolus norepinephrine administrationmanual bolus norepinephrine administration; norepinephrine dose will be at the discretion of the treating anesthesiologists |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous norepinephrine infusion via an infusion pumpPatients 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 | Continuous norepinephrine administration |
| Manual bolus norepinephrine administrationPatients 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 |
Primary outcome
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].
5 secondary outcomes
Area under MAP
Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Cumulative duration of a MAP below
Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Area above MAP
Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Cumulative duration of a MAP above
Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Cumulative dose of norepinephrine
Time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 40744797Vokuhl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Vokuhl, M.D. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous norepinephrine infusion via an infusion pump and Manual bolus norepinephrine administration in people with Blood Pressure and Perioperative Hypotension, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure stability (time frame: Measurement period of 15 minutes starting at the beginning of the anesthetic induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.