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Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy

Primary Purpose

Prostate Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remimazolam
Propofol
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Tumor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group remimazolam

Group propofol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hypotension incidence (unit: event number)
mean arterial pressure (MAP)<65 mmHg for 5 min
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)
Vasopressor dose (unit: mcg for norepinephrine)
total dose of norepinephrine administered
Vasopressor dose (unit for vasopressin)
total dose of vasopressin administered

Secondary Outcome Measures

Full Information

First Posted
September 12, 2023
Last Updated
October 19, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT06093971
Brief Title
Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group remimazolam
Arm Type
Experimental
Arm Description
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.
Arm Title
Group propofol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
remimazolam
Intervention Description
Remimazolam is administered for anesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol is administered for anesthesia induction.
Primary Outcome Measure Information:
Title
Hypotension incidence (unit: event number)
Description
mean arterial pressure (MAP)<65 mmHg for 5 min
Time Frame
during the total anesthesia duration
Title
Amount of hypotension (unit: mmHg)
Description
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)
Time Frame
during the total anesthesia duration
Title
Vasopressor dose (unit: mcg for norepinephrine)
Description
total dose of norepinephrine administered
Time Frame
during the total anesthesia duration
Title
Vasopressor dose (unit for vasopressin)
Description
total dose of vasopressin administered
Time Frame
during the total anesthesia duration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
So Yeon Kim
Phone
82-2-2228-2429
Email
KIMSY326@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
So Yeon Kim
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Yeon Kim
Phone
82-2-2228-2429
Email
KIMSY326@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy

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