NCT06093971

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

November 17, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

September 12, 2023

Last Update Submit

December 8, 2024

Conditions

Prostate Tumor

Outcome Measures

Primary Outcomes (4)

  • Hypotension occurrence (unit: number of patients)

    "MAP\<65mmHg for 1 min

    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)

    during the total anesthesia duration

  • Vasopressor dose (unit: mcg for norepinephrine)

    total dose of norepinephrine administered

    during the total anesthesia duration

  • Vasopressor dose (unit for vasopressin)

    total dose of vasopressin administered

    during the total anesthesia duration

Study Arms (2)

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.

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.

Drug: Propofol

Interventions

remimazolamDRUG

Remimazolam is administered for anesthesia induction.

Group remimazolam
PropofolDRUG

Propofol is administered for anesthesia induction.

Group propofol

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

  • Kim 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.

    PMID: 41233396DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

remimazolamPropofol

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • So Yeon Kim

    Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 23, 2023

Study Start

November 17, 2023

Primary Completion

October 22, 2024

Study Completion

October 22, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)