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NCT Number: NCT07349186

Oscillometric Versus Intraarterial Blood Pressure Monitoring During Robot-Assisted Prostatectomy

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.

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Key information

Conditions

Intraoperative Hypotension

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Alina Bergholz

CONTACT

[email protected]

00494074100

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male patient ≥18 years
  • scheduled for elective robot-assisted (Da Vinci) radical prostatectomy in steep Trendelenburg position
  • planned intraarterial blood pressure monitoring

Exclusion criteria

  • 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

Treatment and study plan

Oscillometric blood pressure monitoring

Other

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 monitoring

Other

In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Area under a MAP <65 mmHg

    Time frame: From the start of surgery until the end of surgery

    Area under a MAP <65 mmHg [mmHg min] (continuous endpoint)

  2. Total duration of MAP <65 mmHg

    Time frame: From the start of surgery until the end of surgery

    Total duration of MAP <65 mmHg [min] (continuous endpoint)

  3. Number of discrete hypotensive episodes

    Time frame: From the start of surgery until the end of surgery

    Number of discrete hypotensive episodes, defined as MAP <65 mmHg sustained for >1 min (count endpoint)

  4. Area above a MAP >100 mmHg

    Time frame: From the start of surgery until the end of surgery

    Area above a MAP >100 mmHg [mmHg min] (continuous endpoint)

  5. Time-weighted average MAP >100 mmHg

    Time frame: From the start of surgery until the end of surgery

    Time-weighted average MAP >100 mmHg [mmHg], calculated from randomization until the end of surgery (continuous endpoint)

  6. Average norepinephrine infusion rate

    Time frame: From the start of surgery until the end of surgery

    Average norepinephrine infusion rate [μg kg-1 min-1] (continuous endpoint)

  7. Total volume of administered crystalloids

    Time frame: From the start of surgery until the end of surgery

    Total volume of administered crystalloids [ml] (continuous endpoint)

Other outcomes

  1. Incidence of a composite binary outcome defined as the occurrence of at least one of the following: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death

    Time frame: Within the first 30 postoperative days

    Incidence of a composite binary outcome defined as the occurrence of at least one of the following within the first 30 postoperative days: renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, or death (binary endpoint)

  2. Incidence of need for renal replacement therapy

    Time frame: Within the first 30 postoperative days

    Incidence of need for renal replacement therapy within the first 30 postoperative days (binary endpoint)

  3. Incidence of myocardial infarction

    Time frame: Within the first 30 postoperative days

    Incidence of myocardial infarction within the first 30 postoperative days (binary endpoint)

  4. Incidence of non-fatal cardiac arrest

    Time frame: Within the first 30 postoperative days

    Incidence of non-fatal cardiac arrest within the first 30 postoperative days (binary endpoint)

  5. Incidence of death

    Time frame: Within the first 30 postoperative days

    Incidence of death within the first 30 postoperative days (binary endpoint)

  6. Incidence of postoperative acute kidney injury

    Time frame: Within the first 7 postoperative days

    Incidence of postoperative acute kidney injury within the first 7 postoperative days (binary endpoint)

Study contacts

Contact information is provided by the study sponsor or research team.

Alina Bergholz

CONTACT

[email protected]

004940 7410 0

Bernd Saugel

CONTACT

Sponsors and collaborators

Lead sponsor

University of Hamburg-Eppendorf

Other

Registry information

Official study title

Oscillometric Versus Intraarterial Blood Pressure Monitoring to Reduce Intraoperative Hypotension During Robot-Assisted Prostatectomy: A Non-Inferiority Randomized Trial

Acronym: PROST-BP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Feb 2, 2026

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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