Prostate TumorNCT06093971
Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy
A study testing remimazolam and Propofol in people with Prostate Tumor, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Tumor
- What is being tested?
- remimazolam and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2023to 22 Oct 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.
Who cannot join
- emergency surgery
- If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.)
- cognitive dysfunction
- Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less
- Patients who did not take renin-angiotensin system blockers on the day of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy: A Randomized Controlled Study
The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure <65mmHg is defined as hypotension).
- Conditions
- Prostate Tumor
- Being tested
- remimazolam, Propofol
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolamDrug
Remimazolam is administered for anesthesia induction.
PropofolDrug
Propofol is administered for anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Group remimazolam | Experimental | During anesthesia induction, the remimazolam group (group R) receives remimazolam (0.2 mg/kg). If necessary, an additional dose of remimazolam (0.1 mg/kg) is administered. Receives: Drug: remimazolam |
| Group propofol | Active comparator | During anesthesia induction, the propofol group (group P) receives propofol (1.0 mg/kg). If necessary, an additional dose of propofol (0.5 mg/kg) is administered. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension occurrence (unit: number of patients)
"MAP<65mmHg for 1 min
Measured: during the total anesthesia duration
Amount of hypotension (unit: mmHg)
time-weighted average MAP <65mmHg => depth of hypotension (mmHg) below a MAP of 65 mmHg * time (min) below a MAP of 65 mmHg)/ total duration of surgery (min)
Measured: during the total anesthesia duration
Vasopressor dose (unit: mcg for norepinephrine)
total dose of norepinephrine administered
Measured: during the total anesthesia duration
Vasopressor dose (unit for vasopressin)
total dose of vasopressin administered
Measured: during the total anesthesia duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start17 Nov 2023
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate TumorStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- So Yeon Kim, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093971
- Sponsor's protocol ID
- 4-2023-0803
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang ZJ, Wu Y, Zhao XY, Qi XS. Ultrasound-guided lung recruitment maneuver in pediatric acute respiratory distress syndrome. Sci Rep. 2026 Apr 6;16(1):16496. doi: 10.1038/s41598-026-43537-1.
PubMed 41942542Kim HJ, Kim N, Kim J, Park JH, Shin HJ, Yang J, Kim SY. Intraoperative hypotension after remimazolam or propofol induction with sevoflurane maintenance in angiotensin II receptor blockers-treated patients: a randomized controlled trial. Sci Rep. 2025 Nov 13;15(1):39805. doi: 10.1038/s41598-025-23469-y.
PubMed 41233396
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06093971
- Acronym / sponsor ID
- 4-2023-0803
- Conditions
- Prostate Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 23 Oct 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.
The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure <65mmHg is defined as hypotension).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group remimazolam | Experimental | Drug: remimazolamDuring anesthesia induction, the remimazolam group (group R) receives remimazolam (0.2 mg/kg). If necessary, an additional dose of remimazolam (0.1 mg/kg) is administered. |
| Group propofol | Active comparator | Drug: PropofolDuring anesthesia induction, the propofol group (group P) receives propofol (1.0 mg/kg). If necessary, an additional dose of propofol (0.5 mg/kg) is administered. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.
Key exclusion criteria (5 listed)
- emergency surgery
- If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.)
- cognitive dysfunction
- Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less
- Patients who did not take renin-angiotensin system blockers on the day of surgery
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 |
|---|---|---|
| remimazolamRemimazolam is administered for anesthesia induction. | Drug | Group remimazolam |
| PropofolPropofol is administered for anesthesia induction. | Drug | Group propofol |
Primary outcome
Hypotension occurrence (unit: number of patients)
Time frame: during the total anesthesia duration
"MAP<65mmHg for 1 min
Amount of hypotension (unit: mmHg)
Time frame: during the total anesthesia duration
time-weighted average MAP <65mmHg => depth of hypotension (mmHg) below a MAP of 65 mmHg * time (min) below a MAP of 65 mmHg)/ total duration of surgery (min)
Vasopressor dose (unit: mcg for norepinephrine)
Time frame: during the total anesthesia duration
total dose of norepinephrine administered
Vasopressor dose (unit for vasopressin)
Time frame: during the total anesthesia duration
total dose of vasopressin administered
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 12 Dec 2024.
- Derived from this study: PubMed 41942542Yang ZJ, Wu Y, Zhao XY, Qi XS. Ultrasound-guided lung recruitment maneuver in pediatric acute respiratory distress syndrome. Sci Rep. 2026 Apr 6;16(1):16496. doi: 10.1038/s41598-026-43537-1.
- Derived from this study: PubMed 41233396Kim HJ, Kim N, Kim J, Park JH, Shin HJ, Yang J, Kim SY. Intraoperative hypotension after remimazolam or propofol induction with sevoflurane maintenance in angiotensin II receptor blockers-treated patients: a randomized controlled trial. Sci Rep. 2025 Nov 13;15(1):39805. doi: 10.1038/s41598-025-23469-y.
- 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.
So Yeon Kim principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam and Propofol in people with Prostate Tumor, run by Yonsei University at 1 site in South Korea.
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 1 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 12 Dec 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 South Korea. 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?
Hypotension occurrence (unit: number of patients) (time frame: during the total anesthesia duration). The study lists 4 primary outcomes in all. 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 NCT06093971, which also lists 2 linked publications.
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 12 Dec 2024.