Oscillometric Versus Intraarterial Blood Pressure Monitoring During Robot-Assisted Prostatectomy (PROST-BP)

January 30, 2026 updated by: Dr. Alina Bergholz, University of Hamburg-Eppendorf

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bernd Saugel

Study Contact Backup

Study Locations

  • Germany
    • Hamburg
      • Hamburg, Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oscillometric blood pressure monitoring
Intraoperative blood pressure will be managed based on oscillometric blood pressure monitoring.
Other: Oscillometric blood pressure monitoring
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.
Active Comparator: Intraarterial blood pressure monitoring
Intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring.
Other: Intraarterial blood pressure monitoring
In patients assigned to intraarterial blood pressure monitoring, intraoperative blood pressure will be managed based on intraarterial blood pressure monitoring per institutional routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the start of surgery until the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Total duration of MAP <65 mmHg [min] (continuous endpoint)
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
Number of discrete hypotensive episodes, defined as MAP <65 mmHg sustained for >1 min (count endpoint)
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
Area above a MAP >100 mmHg [mmHg min] (continuous endpoint)
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
Time-weighted average MAP >100 mmHg [mmHg], calculated from randomization until the end of surgery (continuous endpoint)
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
Average norepinephrine infusion rate [μg kg-1 min-1] (continuous endpoint)
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
Total volume of administered crystalloids [ml] (continuous endpoint)
From the start of surgery until the end of surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within the first 30 postoperative days
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)
Within the first 30 postoperative days
Incidence of myocardial infarction
Time Frame: Within the first 30 postoperative days
Incidence of myocardial infarction within the first 30 postoperative days (binary endpoint)
Within the first 30 postoperative days
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)
Within the first 30 postoperative days
Incidence of death
Time Frame: Within the first 30 postoperative days
Incidence of death within the first 30 postoperative days (binary endpoint)
Within the first 30 postoperative days
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)
Within the first 7 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-101598-BOff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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