Intraoperative HypotensionPROST-BPNCT07349186
Oscillometric Versus Intraarterial Blood Pressure Monitoring During Robot-Assisted Prostatectomy
A study testing Oscillometric blood pressure monitoring and Intraarterial blood pressure monitoring in people with Intraoperative Hypotension, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Oscillometric blood pressure monitoring and Intraarterial blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male patient ≥18 years
- scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
- planned intraarterial blood pressure monitoring
Who cannot join
- patients in whom the attending anesthesiologist considers intraarterial blood pressure monitoring to be mandatory for clinical reasons
- patients participating in another interventional trial likely to influence intraoperative blood pressure management
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bernd Saugel contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Alina Bergholz, 00494074100, a.bergholz@uke.de
About this study
Official title: Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial
The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.
- Conditions
- Intraoperative Hypotension
- Being tested
- Oscillometric blood pressure monitoring, Intraarterial blood pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillometric blood pressure monitoringOther
In patients assigned to oscillometric blood pressure monitoring, clinicians will be blinded to intraarterial blood pressure monitoring and intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring at 2.5-minute intervals.
Intraarterial blood pressure monitoringOther
In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.
| Study group | Role | What they receive |
|---|---|---|
| Oscillometric blood pressure monitoring | Experimental | Intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring. Receives: Other: Oscillometric blood pressure monitoring |
| Intraarterial blood pressure monitoring | Active comparator | Intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring. Receives: Other: Intraarterial blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average MAP <65 mmHg
Time-weighted average MAP <65 mmHg [mmHg], calculated from the start of surgery until the end of surgery (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Secondary outcomes (7)
Area under a MAP <65 mmHg
Area under a MAP <65 mmHg [mmHg min] (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Total duration of MAP <65 mmHg
Total duration of MAP <65 mmHg [min] (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Number of discrete hypotensive episodes
Number of discrete hypotensive episodes, defined as MAP <65 mmHg sustained for >1 min (count endpoint)
Measured: From the start of surgery until the end of surgery
Area above a MAP >100 mmHg
Area above a MAP >100 mmHg [mmHg min] (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Time-weighted average MAP >100 mmHg
Time-weighted average MAP >100 mmHg [mmHg], calculated from randomization until the end of surgery (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Average norepinephrine infusion rate
Average norepinephrine infusion rate [μg kg-1 min-1] (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Total volume of administered crystalloids
Total volume of administered crystalloids [ml] (continuous endpoint)
Measured: From the start of surgery until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start29 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alina Bergholz, University of Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349186
- Sponsor's protocol ID
- 2025-101598-BOff
- Other IDs
- 2025
- Acronym
- PROST-BP
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT07349186
- Acronym / sponsor ID
- PROST-BP / 2025-101598-BOff
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Jan 2026 (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.
The PROST-BP trial is a prospective, single-center, randomized, patient-blinded, non-inferiority trial investigating whether intermittent oscillometric blood pressure monitoring is non-inferior to continuous intraarterial blood pressure monitoring in reducing intraoperative hypotension in patients having robot-assisted radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oscillometric blood pressure monitoring | Experimental | Other: Oscillometric blood pressure monitoringIntraoperative blood pressure will be managed based on oscillometric blood pressure monitoring. |
| Intraarterial blood pressure monitoring | Active comparator | Other: Intraarterial blood pressure monitoringIntraoperative blood pressure will be managed based on intraarterial blood pressure monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male patient ≥18 years
- scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
- planned intraarterial blood pressure monitoring
Key exclusion criteria (2 listed)
- patients in whom the attending anesthesiologist considers intraarterial blood pressure monitoring to be mandatory for clinical reasons
- patients participating in another interventional trial likely to influence intraoperative blood pressure management
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 |
|---|---|---|
| Oscillometric blood pressure monitoringIn patients assigned to oscillometric blood pressure monitoring, clinicians will be blinded to intraarterial blood pressure monitoring and intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring at 2.5-minute intervals. | Other | Oscillometric blood pressure monitoring |
| Intraarterial blood pressure monitoringIn patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine. | Other | Intraarterial blood pressure monitoring |
Primary outcome
Time-weighted average MAP <65 mmHg
Time frame: From the start of surgery until the end of surgery
Time-weighted average MAP <65 mmHg [mmHg], calculated from the start of surgery until the end of surgery (continuous endpoint)
7 secondary outcomes
Area under a MAP <65 mmHg
Time frame: From the start of surgery until the end of surgery
Total duration of MAP <65 mmHg
Time frame: From the start of surgery until the end of surgery
Number of discrete hypotensive episodes
Time frame: From the start of surgery until the end of surgery
Area above a MAP >100 mmHg
Time frame: From the start of surgery until the end of surgery
Time-weighted average MAP >100 mmHg
Time frame: From the start of surgery until the end of surgery
Average norepinephrine infusion rate
Time frame: From the start of surgery until the end of surgery
Total volume of administered crystalloids
Time frame: From the start of surgery until the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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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.
Bernd Saugel contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillometric blood pressure monitoring and Intraarterial blood pressure monitoring in people with Intraoperative Hypotension, run by University of 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Bergholz (004940 7410 0, a.bergholz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average MAP <65 mmHg (time frame: From the start of surgery until the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2026.